Elizabeth Baca, Specialist Leader, Deloitte Consulting, and former Deputy Director, California Governor’s Office of Planning and Research & Elizabeth O’Day, Founder, Olaris, Inc

What if your doctor could predict your heart attack before you had it – and prevent it? Or what if we could cure a child’s cancer by exploiting the bacteria in their gut?

These types of biotechnology solutions aimed at improving human health are already being explored. As more and more data (so called “big data") is available across disparate domains such as electronic health records, genomics, metabolomics , and even life-style information, further insights and opportunities for biotechnology will become apparent. However, to achieve the maximal potential both technical and ethical issues will need to be addressed.

As we look to the future, let’s first revisit previous examples of where combining data with scientific understanding has led to new health solutions.

Biotechnology is a rapidly changing field that continues to transform both in scope and impact. Karl Ereky first coined the term biotechnology in 1919. However, biotechnology’s roots trace back to as early as the 1600s when a Prussian physician, Georg Ernst Stahl, pioneered a new fermentation technology referred to as “zymotechnology.”

Over the next few centuries, “biotechnology” was primarily focused on improving fermentation processes to make alcohol and later food production. With the discovery of penicillin, new applications emerged for human health. In 1981, the Organization for Economic Cooperation and Development (OECD) defined biotechnology as, “the application of scientific and engineering principles to the processing of materials by biological agents to provide the goods and services.”

Today, the Biotechnology Innovation Organization (BIO) defines biotechnology as “technology based on biology - biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet.

In the Fourth Industrial Revolution, biotechnology is poised for its next transformation. It is estimated that between 2010 and 2020 there will be a 50-fold growth of data .

Just a decade ago, many did not even see a need for a smart phone, whereas today, each click, step we take, meal we eat, and more is documented, logged and analyzed on a level of granularity not possible a decade ago.

Concurrent with the collection of personal data, we are also amassing a mountain of biological data (such as genomics, microbiome, proteomics, exposome, transcriptome, and metabolome). This biological-big-data coupled with advanced analytical tools has led to a deeper understanding about fundamental human biology. Further, digitization is revolutionizing health care, allowing for patient reported symptoms, feelings, health outcomes and records such as radiographs and pathology images to be captured as mineable data.

As these datasets grow and have the opportunity to be combined, what is the potential impact to biotechnology and human health? And better still, what is the impact on individual privacy?

Disclaimer: The authors above do not necessarily reflect the policies or positions of the organizations with which they are affiliated.

medical biotechnology essay

The role of big data in biotech breakthroughs

Daniel Heath, Senior Lecturer in the University of Melbourne's Department of Biomedical Engineering & Elizabeth Baca & Elizabeth O’Day

One of the most fundamental and powerful data sets for human health is the human genome. DNA is our biological instruction set composed of billions of repeating chemical groups (thymine, adenine, guanine, and cytosine) that are connected to form a code. A person’s genome is the complete set of his or her DNA code, ie the complete instructions to make that individual.

DNA acts as a template to produce a separate molecule called RNA through the process of transcription. Many RNA molecules in turn act as a template for the production of proteins, a process referred to as translation. These proteins then go on to carry out many of the fundamental cellular tasks required for life. Therefore any unwanted changes in DNA can have downstream effects on RNA and proteins. This can have little to no effect or result in a wide range of diseases such as Huntington’s disease, cystic fibrosis, sickle cell anaemia, and many more.

Genomic sequencing involves mapping the complete set, or part of individual’s DNA code. Being able to detect unwanted changes in DNA not only provides powerful insight to understand disease but can also lead to new diagnostic and therapeutic interventions.

The first human genome sequence was finished in 2003, took 13 years to complete, and cost billions of dollars. Today due to biotech and computational advancements, sequencing a person’s genome costs approximately $1,000 and can be completed in about a day.

Important milestones in the history of genomics

1869 - DNA was first identified

1953 - Structure of DNA established

1977 - DNA Sequencing by chemical degradation

1986 - The first semi-automated DNA sequencing machine produced

2003 - Human genome project sequenced first entire genome at the cost of $3 billion

2005 - Canada launches personal genome project

2007 - 23andMe markets first direct to consumer genetic testing for ancestry of autosomal DNA

2008 - First personal genome sequenced

2012 - England launched (and finished in 2018) 100K genome project

2013 - Saudi Arabia launched the Saudi Human Genome Program

2015 - US launched plan to sequence one million genomes

2015 - Korea launched plan to sequence 10K genomes

2016 - US launched All of Us Research cohort to enroll one million or more participants to collect lifestyle, environment, genetic, and biologic data

2016 - China launched the Precision Medicine initiative with 60 billion RMB

2016 - France started Genomic Medicine 2025 Project

Treatments available today due to DNA technology

Knowing the structure and function of DNA has also enabled us to develop breakthrough biotechnology solutions that have greatly improved the quality of life of countless individuals. A few examples include:

Genetic screenings for diseases. An individual can scan his or her DNA code to look for known mutations linked to disease. Newborns are often screened at birth to identify treatable genetic disorders. For instance, all newborns in the US are screened for a disease called severe combined immunodeficiency (SCID). Individuals with this genetic disease lack a fully functional immune system and usually die within a year, if not treated. However, due to regular screenings, these newborns can receive a bone marrow transplant, which has a more than 90% of success rate to treat SCID. A well-known example in adults is screening women for mutations in the BRCA1 and BRCA2 genes as risk factor for developing breast cancer or ovarian cancer.

Recombinant protein production. This technology allows scientists to introduce human genes into microorganisms to produce human proteins that can be introduced back to patients to carry out vital functions. In 1978, the company Genentech developed a process to recombinantly produce human insulin, a protein needed to regulate blood glucose. Recombinant insulin is still used to treat diabetes.

CAR T cells . CAR T cell therapy is a technique to help your immune system recognize and kill cancer cells. Immune cells, called T-cells, from a cancer patient are isolated and genetically engineered to express receptors that allow them to identify cancer cells. When these modified T cells are put back into the patient they can help find and kill the cancer cells. Kymriah, used to treat a type of leukemia, and Yescarta, used to treat a type of lymphoma are examples of FDA approved CAR T cell treatments.

Gene therapy. The goal of gene therapy is to replace a missing or defective gene with a normal one to correct the disorder. The first in vivo gene therapy drug, Luxterna, was approved by the FDA in 2017 to treat an inherited degenerative eye disease called Leber’s congenital amaurosis.

Disclaimer: The authors above do not necessarily reflect the policies or positions of the organizations with which they are affiliated .

Frontiers in DNA technology

Our understanding of genetic data continues to lead to new and exciting technologies with the potential to revolutionize and improve our health outcomes. A few examples being developed are described below.

Organoids for drug screening . Organoids are miniature and simplified organs that can be developed outside the body with a defined genome. Organoid systems may one day be used to discover new drugs, tailor treatments to a particular person’s disease or even as treatments themselves.

CRISPR-Cas9 . This is a form of gene therapy - also known as genetic engineering - where the genome is cut at a desired location and existing genes can either be turned off or modified. Animal models have shown that this technique has great promise in the treatment of many hereditary diseases such as sickle cell disease, haemophilia, Huntington’s disease, and more.

We believe sequencing will become a mainstay in the future of human health.

While genomic data is incredibly insightful, it is important to realize, genomics rarely tells the complete story.

Except for rare cases, just because an individual has a particular genetic mutation does not mean they will develop a disease. Genomics provides information on “what could happen” to an individual. Additional datasets such the microbiome, metabolome, lifestyle data and others are needed to answer what will happen.

The role of the microbiome

Elizabeth O’Day & Elizabeth Baca

The microbiome is sometimes referred to as the 'essential organ', the'forgotten organ', our 'second genome' or even our 'second brain'. It includes the catalog of approximately 10-100 trillion microbial cells (bacteria, archea, fungi, virus and eukaryotic microbes) and their genes that reside in each of us. Estimates suggest we have 150 times more microbial DNA from more than 10,000 different species of known bacteria than human DNA.

Microbes reside everywhere (mouth, stomach, intestinal tract, colon, skin, genitals, and possibly even the placenta). The function of the microbiome differs according to different locations in the body and with different ages, sexes, races and diets of the host. Bacteria in the gut digest foods, absorb nutrients, and produce beneficial products that would otherwise not be accessible. In the skin, microbes provide a physical barrier protecting against foreign pathogens through competitive exclusion, and production of antimicrobial substances. In addition, microbes help regulate and influence the immune system. When there is an imbalance in the microbiome, known as dysbiosis, disease can develop. Chronic diseases such as obesity, inflammatory bowel disease, diabetes mellitus, metabolic syndrome, atherosclerosis, alcoholic liver disease (ALD), nonalcoholic fatty liver disease (NAFLD), cirrhosis, hepatocellular carcinoma and other conditions are linked to improper microbiome functioning.

Milestones in our understanding of the microbiome

1680s - Dutch scientist Antonie van Leeuwenhoek compared his oral and fecal microbiota. He noted striking differences in microbes between these two habitats and also between samples from individuals in different states of health.

1885 - Theodor Escherich first describes and isolates Escherichia coli (E. coli) from the feces of newborns in Germany

1908 - Elie Metchnikoff, Russian zoologist, theorized health could be enhanced and senility delayed by bacteria found in yogurt

1959 - Germ-free animals (mice, rats, rabbits, guinea pigs, and chicks) reared in stainless steel in plastic housing to study the effects of health in microbe-free environments

1970 - Dr. Thomas D. Luckey estimates 100 billion colonies of microbes in one gram of human intestinal fluid or feces.

1995 - Craig Venter and a team of researchers sequence the genome of bacterium Haemophilus influenza, making it the first organism to have its genome completely sequenced.

1996 - The first human fecal sample is sequenced using 16S rRNA sequencing.

2001- Scientist Joshua Lederberg credited with coining term “microbiome”.

2005 - Researchers identify bacteria in amniotic fluid of babies born via C-section

2006- First metagenomic analysis of the human gut microbiome is conducted

2007- NIH sponsored Human Microbiome Project (HMP) launches a study to define how the microbial species affect humans and their relationships to health

2009- First microbiome study showing an association between gut microbiome in lean and obese adults

2011- German researchers identify 3 enterotypes in the human gut microbiome: Baceroids, Prevotella, and Ruminococcus

2011- Gosalbes performed the first metatransciptomic analysis of healthy human gut microbiota

2012 - HMP unveils first “map” of microbes inhabiting healthy humans. Results generated from 80 collaborating scientific institutions found more than 10,000 microbial species occupy the human ecosystem, comprising trillions of cells and making up 1-3% of the body’s mass.

2012 - American Gut Project founded, providing an open-to-the-public platform for citizen scientists seeking to analyze their microbiome and compare it to the microbiomes of others.

2014 - The Integrative Human Microbiome Project (iHMP), begins with goal of studying 3 microbiome-associated conditions.

2016 - The Flemish Gut Flora Project, one of the world’s largest population-wide studies on variations in gut microbiota publishes analysis on more than 1,100 human stool samples.

2018 - The American Gut Project publishes the largest study to date on the microbiome. The results include microbial sequence data from 15,096 samples provided by11,336 participants across the US, UK, Australia and 42 other countries.

What solutions are alre ady (or could be) derived from this dataset?

Biotechnology solutions based off microbiome data have already been developed or are in the process of development. A few key examples are highlighted below:

Probiotics . Probiotics are beneficial bacteria that may prevent or treat certain disease. They were first theorized in 1908 and are now a common food additive. From yogurts to supplements, various probiotics are available for purchase in grocery stores and pharmacies, claiming various benefits. For example probiotic VSL#3 has been shown to reduce liver disease severity and hospitalization in patients with cirrhosis.

Diagnostics . Changes in composition of particular microbes are noted as potential biomarkers. An example includes the ratio of Bifidobacterium to Enterobacteriaceae know as the B/E ratio. A B/E greater than 1 suggests a healthy microbiome and a B/E less than 1 could suggest cirrhosis or particular types of infection.

Fecal Microbiome transplantation (FMT). Although not FDA-approved, fecal microbiome transplantation (FMT) is a widely used method where a fecal preparation from a healthy stool donor is transplanted into the colon of patient via colonoscopy, naso-enteric tube, or capsules. FMT has been used to treat Clostridium difficile infections with 80-90% cure rates (far better efficacy than antibiotics).

Therapeutics. The microbiome dataset is also producing several innovative therapies. Development of bacteria consortia and single strains (both natural and engineered) are in clinical development. Efforts are also underway to identify and isolate microbiome metabolites with important function, such as the methicillin-resistant antibiotics that were identified by primary sequencing of the human gut microbiome.

By continuing to build the microbiome dataset and expand our knowledge of host-microbiome interactions, we may be able correct various states of disease and improve human health.

The role of clinical data, and the doctor's 'sixth sense'

Pam Randhawa, CEO and founder of Empiriko Corporation, Andrew Steinberg, Watson Institute for International and Public Affairs, Brown University, Elizabeth Baca & Elizabeth O’Day

For centuries, physicians were limited by the data they were able to obtain via external examination of an individual patient or an autopsy.

More recently, technological advancements have enabled clinicians to identify and monitor internal processes which were previously hidden within living patients.

One of the earliest examples of applied technology occurred in the 1890s when German physicist Wilhelm Röntgen discovered the potential medical applications of X-rays.

Since that time, new technologies have expanded clinical knowledge in imaging, genomics, biomarkers, response to medications, and the microbiome. Collectively, this extended database of high quality, granular information has enhanced the physician’s diagnostic capabilities and has translated into improved clinical outcomes.

medical biotechnology essay

Today’s clinicians increasingly rely on medical imaging and other technology- based diagnostic tools to non-invasively look below the surface to monitor treatment efficacy and screen for pathologic processes, often before clinical symptoms appear.

In addition, the clinician’s senses can be extended by electronic data capture systems, IVRS, wearable devices, remote monitoring systems, sensors and iPhone applications. Despite access to this new technology, physicians continue to obtain a patient’s history in real-time followed by a hands-on assessment of physical findings, an approach which can be limited by communication barriers, time, and the physician’s ability to gather or collate data.

One of the largest examples of clinical data collection, integration and analysis occurred in the 1940s with the National Heart Act which created the National Heart Institute and the Framingham Heart Study. The Framingham Original Cohort was started in 1948 with 5,209 men and women between the ages of 30-62 with no history of heart attack or stroke.

Over the next 71 years, the study evolved to gather clinical data for cardiovascular and other medical conditions over several generations. Prior to that time the concepts of preventive medicine and risk factors (a term coined by the Framingham study) were not part of the medical lexicon. The Framingham study enabled physicians to harness observations gathered from individuals’ physical examination findings, biomarkers, imaging and other physiologic data on a scale which was unparalleled.

The adoption of electronic medical records helped improve data access, but in their earliest iterations only partially addressed the challenges of data compartmentalization and interoperability (silos).

Recent advances in AI applications, EMR data structure and interoperability have enabled clinicians and researchers to improve their clinical decision making. However, accessibility, cost and delays in implementing global interoperability standards have limited data accessibility from disparate systems and have delayed introduction of EMRs in some segments of the medical community.

To this day, limited interoperability, the learning curve and costs associated with implementation are cited as major contributors to physician frustration, burnout and providers retiring early from patient care settings.

However, an interoperability platform known as Fast Healthcare Interoperability Resources (FHIR, pronounced "FIRE") is being developed to exchange electronic health records and unlock silos. The objective of FHIR is to facilitate interoperability between legacy health care systems. The platform facilitates easier access to health data on a variety of devices (e.g., computers, tablets, cell phones), and allows developers to provide medical applications which can be easily integrated into existing systems.

As the capacity to gather information becomes more meaningful, the collection, integration, analysis and format of clinical data submission requires standardization. In the late 1990s, the Clinical Data Interchange Standards Consortium (CDISC) was formed “to develop and support global, platform-independent data standards which enable information system interoperability to improve medical research”. Over the past several years, CDISC has developed several models to support the organization of clinical trial data.

Milestones in the discovery/development of clinical data and technologies

500BC - The world's first clinical trial recorded in the “Book of Daniel” in The Bible

1747 - Lind’s Scurvy trial which contained most characteristics of a controlled trial

1928 - American College of Surgeons sought to improve record standards in clinical settings

1943 - First double blinded controlled trial of patulin for common cold (UK Medical Research Council)

1946 - First randomized controlled trial of streptomycin in pulmonary tuberculosis conducted (UK Medical Research Council)

1946 - American physicists Edward Purcell and Felix Bloch independently discover nuclear magnetic resonance (NMR).

1947 - First International guidance on the ethics of medical research involving human subjects – Nuremberg Code

1955 - Scottish physician Ian Donald begins to investigate the use of gynecologic ultrasound.

1960 - First use of endoscopy to examine a patient’s stomach.

1964 - World Medical Association guidelines on use of human subjects in medical research (Helsinki Declaration)

1967 - 1971 - English electrical engineer Godfrey Hounsfield conceives the idea for computed tomography. First CT scanner installed in Atkinson Morley Hospital, Wimbledon, England. First patient brain scan performed - October 1971.

1972 - First Electronic Health Record designed

1973 - American chemist Paul Lauterbur produces the first magnetic resonance image (MRI) using nuclear magnetic resonance data and computer calculations of tomography.

1974 - American Michael Phelps develops the first positron emission tomography (PET) camera and the first whole-body system for human and animal studies.

1977 - First MRI body scan is performed on a human using an MRI machine developed by American doctors Raymond Damadian, Larry Minkoff and Michael Goldsmith.

1990 - Ultrasound becomes a routine procedure to check fetal development and diagnose abnormalities.

Early-Mid 1990 - Development of electronic data capture (EDC) system for clinical trials (electronic case report forms)

1996 - International Conference on Harmonization published Good Clinical Practice which has become the universal standard for ethical conduct of clinical trials.

Late 1990s - The Clinical Data Interchange Standards Consortium (CDISC) was formed with the mission “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research”

2009 - American Recovery and Reinvestment Act of 2009 passed including $19.2 Billion of funding for hospitals and physicians to adopt EHRs

2014 - HL-7 International published FHIR as a "Draft Standard for Trial Use" (DSTU)

Emerging Solutions

The convergence of scientific knowledge, robust clinical data, and engineering in the digital age has resulted in the development of dynamic healthcare technologies which allow for earlier and more accurate disease detection and therapeutic efficacy in individuals and populations.

The emergence of miniaturized technologies such as handheld ultrasound, sleep tracking, cardiac monitoring and lab-on-a-chip technologies will likely accelerate this trend. Among the most rapidly evolving fields in data collection, has been in clinical laboratory medicine where continuous point-of-care testing, portable mass spectrometers, flow analysis, PCR, and use of MALDI-TOF mass spectrometry for pathogen identification provide insight into numerous clinically relevant biomarkers.

Coupled with high resolution and functional medical imaging the tracking of these biomarkers gives a metabolic fingerprint of disease, thereby opening a new frontier in “Precision Medicine”.

Beyond these capabilities, artificial intelligence (AI) applications are being developed to leverage the sensory and analytic capabilities of humans via medical image reconstruction and noise reduction. AI solutions for computer-aided detection and radiogenomics enable clinicians to better predict risk and patient outcomes.

These technologies stratify patients into cohorts for more precise diagnosis and treatment. As AI technology evolves, the emergence of the “virtual radiologist” could become a reality. Since the humans cannot gather, collate and quickly analyze this volume of granular information, these innovations will replace time-intensive data gathering with more cost-effective analytic approaches to clinical decision-making.

As the population ages and lives longer, increasing numbers of people will be impacted by multiple chronic conditions which will be treated contemporaneously with multiple medications. Optimally these conditions will be monitored at home or in another remote setting outside of a hospital.

Platforms are under development where the next generation of laboratory technologies will be integrated into an interoperable system which includes miniaturized instruments and biosensors. This will be coupled with AI driven clinical translation models to assess disease progression and drug effectiveness.

This digital data will be communicated in real time to the patient’s electronic medical record. This type of system will shift clinical medicine from reactive to proactive care and provide more precise clinical decision-making.

With this enhanced ability to receive more granular, high quality clinical information comes an opportunity and a challenge. In the future, the ability to leverage the power of computational modeling, artificial intelligence will facilitate a logarithmic explosion of clinically relevant correlations.

This will enable discovery of new therapies and novel markers which will empower clinicians to more precisely manage risk for individuals and populations. This form of precision medicine and predictive modeling will likely occur across the disease timeline, potentially even before birth.

Stakeholders will need to pay close attention to maintaining the privacy and security of patient data as it moves across different platforms and devices.

However, the potential benefits of this interoperability far outweigh the risks. This will raise a host of ethical questions, but also the potential for a series of efficiencies which will make healthcare more accessible and affordable to a greater number of people.

Lifestyle and environmental data

Jessica Shen, Vice President at Royal Philips, Elizabeth Baca & Elizabeth O’Day

In medicine and public health there is often tension between the effect of genetics verses the effect of the environment, and which plays a bigger role in health outcomes. But rather than an either or approach, science supports that both factors are at play and contribute to health and disease.

For instance, one can be genetically at risk for diabetes, but with excellent diet and exercise and a healthy lifestyle, the disease can still be avoided.

In fact, many people who are newly diabetic or pre-diabetic can reverse the course of their disease through lifestyle modifications. Alternatively, someone at risk of asthma who is exposed to bad air quality can go on to develop the disease, but then become relatively asymptomatic in an environment with less triggers.

The growing literature on the importance of lifestyle, behaviours, stressors, social, economic, and environmental factors, (the latter also known as the social determinants of health), have been relatively hard to capture for real time clinical information.

It has been especially challenging to integrate all of the data together for better insight. However, that is changing. In this new data frontier, the growth of data in the lifestyle and environment area offer huge potential to bridge gaps, increase understanding of health in daily life, and tailor treatments for a precision health approach.

1881 - Blood pressure cuff invented

2010 - Asthmapolis founded with sensor to track environmental data on Asthma/COPD rescue inhalers

2011 - First digital FDA blood pressure cuff approved and links to digital phone

2012 - AliveCor receives FDA approval for EKG monitor with Iphone

2017 - 325,000 mobile health apps

2017 - FDA releases Digital Health Innovation Action Plan

2018 - FDA approves first continuous glucose monitor via implantable sensor and mobile app interface

What are some of the benefits suggested with the use of lifestyle data?

Mobile technology has enabled more continuous monitoring in daily life outside of the clinic and in real world settings. As an example the traditional blood pressure cuff invented over 130 years ago was only updated in the last decade to allow remote readings which are digitally captured.

Sensors are now being included to measure environmental factors such as air quality, humidity, and temperature. Other innovations are allowing mood to be captured in real time, brain waves for biofeedback, and other biometrics to improve fitness, nutrition, sleep, and even fertility.

The personal analytics capabilities of devices designed to collect lifestyle data can contribute to health by aiding preventive care and help with the management of ongoing health problems.

Identification of health problems through routine monitoring may evolve into a broad system encompassing many physiologic functions; such as:

  • sleep disturbances (severe snoring; apnea)
  • neuromuscular conditions (identification of early Parkinson’s with the analysis of muscular motion)
  • cardiac problems such as arrhythmias including atrial fibrillation
  • sensors to detect early Alzheimer’s disease via voice changes

The Apple Watch has provided documentation on the use of the device for arrhythmia detection, the series 4 version can generate a ECG similar to a Lead 1 electrocardiogram; claims related to these functions were cleared by FDA (Class II, de Novo). Additional wearable technologies are likely to incorporate such functions in the future.

The instant feedback available with the use of a wearable sensory device can serve as an aid to the management of many chronic conditions including but not limited to diabetes, pulmonary problems, and hypertension.

Many studies have documented the cardiovascular benefits of life-long physical activity. Several biotechnology solutions, designed to track activity with analytical feedback tools provide the opportunity to encourage physical activity to promote health, perhaps even modifying behaviour. A Cochrane Review (Bravata, 2007. PMID 18029834) concluded there was short-term evidence of significant physical activity increase and associated health improvement with the use of a pedometer to increase activity. The feedback associated with today’s data driven health improvement applications should increase the effectiveness over a simple mechanical pedometer. Studies are underway in multiple settings to support the use of activity trackers and feedback-providing analysis tools as beneficial to longer-term health.

Use in research settings

In many circumstances, the collection of clinical data for a formal trial or for use in longitudinal studies is facilitated by direct observation as provided by a network-attached sensor system.

What may future developments support?

The development of ‘smart clothing’ and wearable tech-enabled jewellery as well as implantable devices will lead to less obtrusive observation instruments recording many more physiological indicators.

Wireless networking, both fixed and mobile, continue their stepwise jumps in speed and this capacity growth (5G and Wifi-6 with megabit internet) will support massive increases in the volume of manageable data.

Connecting sensor derived observations to other indicators of health such as medical history and genetics will further expand our understanding of disease and how to live our most healthy lives.

However, for this potential to be realized significant technical and ethical issues must first be addressed.

How to put patients at the centre of innovation

Elissa Prichep, Precision Medicine Lead at the World Economic Forum, Elizabeth Baca & Elizabeth O’Day

The Global Future Council on biotechnology has examined the exponential growth of data across different areas which has lead to breakthrough technologies transforming human health and medicine. Yet let us be clear: it was not some abstract understanding of data that lead to these solutions, it was real data, derived from real individuals, individuals like you. Your data, or data from someone like you, led to those solutions. Did you know that? Did you consent to that?

We believe individuals should feel empowered by contributing to these datasets. You are changing human health- there’s perhaps nothing more important. However, in going through this analysis we were repeatedly concerned about the whether the individuals (“data-contributors”) were properly informed or consented by “data collectors” to use their data?

As we have documented here, amazing, breakthrough technologies and medicines can arise from these datasets. However, there are nefarious situations that could develop as well.

We believe new norms between "data-collectors" and "data contributors"need to be established if we want data to continue to drive the development of biotech solutions to improve human health.

How we think about privacy will change

Although the emergence of digital data through electronic health records, mobile applications, cloud storage and more have had great benefits, there are also privacy risks.

The identification of parties associated with ‘anonymous’ data becomes more likely as more sophisticated algorithms are developed; data that is secure and private today may not be so in the future. Data privacy concerns and data theft along with device hacking are a serious concern today and will only become more so as the volume and types of data collected increase.

As more data is combined, there is a greater risk of reidentification or privacy breaches. For example, when a Harvard professor was able to reidentify more than 40% of the participants in the anonymous genetic study, The Personal Genome Project.

Additionally, as other types of data are added in for health purposes, in retail for example, there is the risk that reidentification can expose private health details, for example when Target identified the pregnancy of a teenage girl to her family.

There must be value from these solutions to entertain the risks associated with combining the data. Integrating patient and participants at the centre of design ensures informed consent and a better likelihood of value that balances the risks and trade-offs.

Inclusion of diverse populations is important for the new insights to have a positive impact

The benefits and risks a patient can expect from an intervention can depend heavily on that person’s unique biological make-up. A 2015 study found that roughly 20% of new drugs approved in the previous six years demonstrated different responses across different racial and ethnic groups.

However, therapeutics are often put on the market without an understanding of the variability in efficacy and safety across patients because that is not assessed in clinical trials, either due to lack of diversity in the trial, lack of asking the right questions, or both. In the US, it is estimated that 80-90% of clinical trial participants are white despite FDA efforts to expand recruitment.

Without an intentional effort, the amassed new knowledge through biotech solutions, if not done with a diverse population, will not yield accurate insight. If the biotech solutions are not representative of the population, there is the potential to increase health disparities.

For example, genetic studies incorrectly inferred an increased risk of hypertrophic cardiomyopathy for African Americans since the genetic insights were largely gathered from anglo populations.

There are many reasons that participation has been so low in research, but authentic engagement, understanding the historical context, and intentionally funding research to increase participation and improve diversity in translational efforts are already on their way such as the All of Us Cohort and the California Initiative to Advance Precision Medicine.

Inclusive participation will help understand where people truly are in their health journey

In the clinical setting, patient centeredness also needs to occur. Healthy individuals are amassing more and more data about themselves and patients with chronic disease are also starting to rely on applications to track everything from sleep to environmental exposures to mood, but this is currently not used to increase insight for health and illness.

As patients and healthy people take charge of their data, it can only be used if they agree to share it. As biotech solutions are developed, integrating data across all the various areas will be vital to truly have an impact.

Next Steps in Biotech Health Solutions

At the start of this series, we asked: what if your doctor could predict your heart attack before you had it? Research is underway to do just that through combining data from the proteome, patient reported symptoms, and biosensors.

Big data analysis is also already yielding new leads to paediatric cancer when looking at the genetic information of tumors. In the future, this is likely to move beyond better treatment to better prevention and earlier detection. And in the case where treatment is needed, a more tailored option could be offered.

The impact of this data on improved health is exciting and impacts each of us. As data grows, increased understanding does as well. Each of us has the opportunity to be a partner in the new data frontier.

References:

- History of ‘Biotechnogy.’ Nature article Feb 1989 - Allan T. Bull, Geoffrey Holt, and Malcolm D. Lilly, Biotechnology: International Trends and Perspectives (Paris: OECD, 1982) - https://www.bio.org/what-biotechnology - https://insidebigdata.com/2017/02/16/the-exponential-growth-of-data/ - Goodrich, et al. 2014. Human genetics shapes the gut microbiome. Cell. 159(4): 789-99. - https://ghr.nlm.nih.gov/primer/traits/longevity - https://www.forbes.com/sites/adamtanner/2013/04/25/harvard-professor-re-identifies-anonymous-volunteers-in-dna-study/#203da9c992c9 - https://slate.com/human-interest/2014/06/big-data-whats-even-creepier-than-target-guessing-that-youre-pregnant.html - https://www.healio.com/cardiology/genetics-genomics/news/online/%7B006969bb-6ca2-44aa-843a-31c12874b0dc%7D/genetic-tests-may-be-misdiagnosing-hypertrophic-cardiomyopathy-in-black-americans - http://opr.ca.gov/ciapm/ https://allofus.nih.gov - http://opr.ca.gov/ciapm/ - http://opr.ca.gov/ciapm/projects/2016/Early_Prediction_Cardiovascular_Events.html - http://opr.ca.gov/ciapm/projects/2015/California_Kids_Cancer_Comparison.html

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An Introduction to Biotechnology

Varsha gupta.

5 Institute of Biosciences and Biotechnology, Chhatrapati Shahu Ji Maharaj University, Kanpur, UP India

Manjistha Sengupta

6 George Washington University, Washington DC, USA

Jaya Prakash

7 Orthopaedics Unit, Community Health Centre, Kanpur, UP India

Baishnab Charan Tripathy

8 School of Life sciences, Jawaharlal Nehru University, New Delhi, India

Biotechnology is multidisciplinary field which has major impact on our lives. The technology is known since years which involves working with cells or cell-derived molecules for various applications. It has wide range of uses and is termed “technology of hope” which impact human health, well being of other life forms and our environment. It has revolutionized diagnostics and therapeutics; however, the major challenges to the human beings have been threats posed by deadly virus infections as avian flu, Chikungunya, Ebola, Influenza A, SARS, West Nile, and the latest Zika virus. Personalized medicine is increasingly recognized in healthcare system. In this chapter, the readers would understand the applications of biotechnology in human health care system. It has also impacted the environment which is loaded by toxic compounds due to human industrialization and urbanization. Bioremediation process utilizes use of natural or recombinant organisms for the cleanup of environmental toxic pollutants. The development of insect and pest resistant crops and herbicide tolerant crops has greatly reduced the environmental load of toxic insecticides and pesticides. The increase in crop productivity for solving world food and feed problem is addressed in agricultural biotechnology. The technological advancements have focused on development of alternate, renewable, and sustainable energy sources for production of biofuels. Marine biotechnology explores the products which can be obtained from aquatic organisms. As with every research area, the field of biotechnology is associated with many ethical issues and unseen fears. These are important in defining laws governing the feasibility and approval for the conduct of particular research.

Introduction

The term “ biotechnology” was coined by a Hungarian engineer Karl Ereky, in 1919, to refer to the science and methods that permit products to be produced from raw materials with the aid of living organisms. Biotechnology is a diverse field which involves either working with living cells or using molecules derived from them for applications oriented toward human welfare using varied types of tools and technologies. It is an amalgamation of biological science with engineering whereby living organisms or cells or parts are used for production of products and services. The main subfields of biotechnology are medical (red) biotechnology, agricultural (green) biotechnology, industrial (white) biotechnology, marine (blue) biotechnology, food biotechnology, and environmental biotechnology (Fig. 1.1 .). In this chapter the readers will understand the potential applications of biotechnology in several fields like production of medicines; diagnostics; therapeutics like monoclonal antibodies, stem cells, and gene therapy; agricultural biotechnology; pollution control ( bioremediation); industrial and marine biotechnology; and biomaterials, as well as the ethical and safety issues associated with some of the products.

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Major applications of biotechnology in different areas and some of their important products

The biotechnology came into being centuries ago when plants and animals began to be selectively bred and microorganisms were used to make beer, wine, cheese, and bread. However, the field gradually evolved, and presently it is the use or manipulation of living organisms to produce beneficiary substances which may have medical, agricultural, and/or industrial utilization. Conventional biotechnology is referred to as the technique that makes use of living organism for specific purposes as bread/cheese making, whereas modern biotechnology deals with the technique that makes use of cellular molecules like DNA, monoclonal antibodies, biologics, etc. Before we go into technical advances of DNA and thus recombinant DNA technology, let us have the basic understanding about DNA and its function.

The foundation of biotechnology was laid down after the discovery of structure of DNA in the early 1950s. The hereditary material is deoxyribonucleic acid (DNA) which contains all the information that dictates each and every step of an individual’s life. The DNA consists of deoxyribose sugar, phosphate, and four nitrogenous bases (adenine, guanine, cytosine, and thymine). The base and sugar collectively form nucleoside, while base, sugar, and phosphate form nucleotide (Fig. 1.2 ). These are arranged in particular orientation on DNA called order or sequence and contain information to express them in the form of protein. DNA has double helical structure, with two strands being complimentary and antiparallel to each other, in which A on one strand base pairs with T and G base pairs with C with two and three bonds, respectively. DNA is the long but compact molecule which is nicely packaged in our nucleus. The DNA is capable of making more copies like itself with the information present in it, as order or sequence of bases. This is called DNA replication. When the cell divides into two, the DNA also replicates and divides equally into two. The process of DNA replication is shown in Fig. 1.3 , highlighting important steps.

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The double helical structure of DNA where both strands are running in opposite direction. Elongation of the chain occurs due to formation of phosphodiester bond between phosphate at 5′ and hydroxyl group of sugar at 3′ of the adjacent sugar of the nucleotide in 5–3′ direction. The sugar is attached to the base. Bases are of four kinds: adenine ( A ), guanine ( G ) (purines), thymine ( T ), and cytosine ( C ) (pyrimidines). Adenine base pairs with two hydrogen bonds with thymine on the opposite antiparallel strand and guanine base pairs with three hydrogen bonds with cytosine present on the opposite antiparallel strand

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The process of DNA replication. The DNA is densely packed and packaged in the chromosomes. The process requires the action of several factors and enzymes. DNA helicase unwinds the double helix. Topoisomerase relaxes DNA from its super coiled nature. Single-strand binding proteins bind to single-stranded open DNA and prevent its reannealing and maintains strand separation. DNA polymerase is an enzyme which builds a new complimentary DNA strand and has proofreading activity. DNA clamp is a protein which prevents dissociation of DNA polymerase. Primase provides a short RNA sequence for DNA polymerase to begin synthesis. DNA ligase reanneals and joins the Okazaki fragments of the lagging strand. DNA duplication follows semiconservative replication, where each strand serves as template which leads to the production of two complimentary strands. In the newly formed DNA, one strand is old and the other one is new (semiconservative replication). DNA polymerase can extend existing short DNA or RNA strand which is paired to template strand and is called primer. Primer is required as DNA polymerase cannot start the synthesis directly. DNA polymerase is capable of proofreading, that is, correction of wrongly incorporated nucleotide. One strand is replicated continuously with single primer, and it is called as leading strand. Other strand is discontinuous and requires the addition of several primers. The extension is done in the form of short fragments called as Okazaki fragments. The gaps are sealed by DNA ligase. Replication always occurs in 5′–3′ direction

DNA contains whole information for the working of the cell. The part of the DNA which has information to dictate the biosynthesis of a polypeptide is called a “gene.” The arrangement or order of nucleotides determines the kind of proteins which we produce. Each gene is responsible for coding a functional polypeptide. The genes have the information to make a complimentary copy of mRNA. The information of DNA which makes RNA in turn helps cells to incorporate amino acids according to arrangement of letters for making many kinds of proteins. These letters are transcribed into mRNA in the form of triplet codon, where each codon specifies one particular amino acid. The polypeptide is thus made by adding respective amino acids according to the instructions present on RNA. Therefore, the arrangement of four bases (adenine, guanine, cytosine, and thymine) dictates the information to add any of the 20 amino acids to make all the proteins in all the living organisms. Few genes need to be expressed continuously, as their products are required by the cell, and these are known as “constitutive genes.” They are responsible for basic housekeeping functions of the cells. However, depending upon the physiological demand and cell’s requirement at a particular time, some genes are active and some are inactive, that is, they do not code for any protein. The information contained in the DNA is used to make mRNA in the process of “ transcription” (factors shown in Table 1.1 ). The information of mRNA is used in the process of “ translation” for production of protein. Transcription occurs in the nucleus and translation in the cytoplasm of the cell. In translation several initiation factors help in the assembly of mRNA with 40S ribosome and prevent binding of both ribosomal subunits; they also associate with cap and poly(A) tail. Several elongation factors play an important role in chain elongation. Though each cell of the body has the same genetic makeup, but each is specialized to perform unique functions, the activation and expression of genes is different in each cell. Thus, one type of cells can express some of its genes at one time and may not express the same genes some other time. This is called “temporal regulation” of the gene. In the body different cells express different genes and thus different proteins. For example, liver cell and lymphocyte, would express different genes. This is known as spatial regulation of the gene. Therefore, in the cells of the body, the activation of genes is under spatial regulation (cells present at different locations and different organs produce different proteins) and temporal regulation (same cells produce different proteins at different times). The proteins are formed by the information contained in the DNA and perform a variety of cellular functions. The proteins may be structural (responsible for cell shape and size), or they may be functional like enzymes, signaling intermediates, regulatory proteins, and defense system proteins. However, any kind of genetic defect results in defective protein or alters protein folding which can compromise the functioning of the body and is responsible for the diseases. Figure 1.4 shows the outline of the process of transcription and translation with important steps.

Factors involved in transcription process

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It shows the process of transcription and translation. Transcription occurs in the nucleus and requires the usage of three polymerase enzymes. RNApol I for rRNA, pol II for mRNA, and pol III for both rRNA and tRNA. RNApol II initiates the process by associating itself with seven transcription factors, TFIIA, TFIIB, TFIID, TFIIE, TFIIH, and TFIIJ. After the synthesis, preRNA transcript undergoes processing to form mRNA by removal of introns by splicing and polyadenylation and capping. Protein synthesis is initiated by formation of ribosome and initiator tRNA complex to initiation codon (AUG) of mRNA and involves 11 factors. Chain elongation occurs after sequential addition of amino acids by formation of peptide bonds. Then polypeptide can fold or conjugate itself to other biomolecules and may undergo posttranslational modifications as glycosylation or phosphorylation to perform its biological functions

The biotechnological tools are employed toward modification of the gene for gain of function or loss of function of the protein. The technique of removing, adding, or modifying genes in the genome or chromosomes of an organism to bring about the changes in the protein information is called genetic engineering or recombinant DNA technology (Fig. 1.5 ). DNA recombination made possible the sequencing of the human genome and laid the foundation for the nascent fields of bioinformatics, nanomedicine, and individualized therapy. Multicellular organisms like cows, goats, sheep, rats, corn, potato, and tobacco plants have been genetically engineered to produce substances medically useful to humans. Genetic engineering has revolutionized medicine, enabling mass production of safe, pure, more effective versions of biochemicals that the human body produces naturally [ 20 – 22 ].

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The process of recombinant DNA technology. The gene of interest from human nucleus is isolated and cloned in a plasmid vector. The gene is ligated with the help of DNA ligase. The vector is transformed into a bacterial host. After appropriate selections, the gene is amplified when bacteria multiply or the gene can be sequenced or the gene can be expressed to produce protein

The technological advancements have resulted in (1) many biopharmaceuticals and vaccines, (2) new and specific ways to diagnose, (3) increasing the productivity and introduction of quality traits in agricultural crops, (4) the ways to tackle the pollutants efficiently for sustainable environmental practices, (5) helped the forensic experts by DNA fingerprinting and profiling, (6) fermentation technology for production of industrially important products. The list is very long with tremendous advancements and products which have boosted the economy of biotechnology sector worldwide [ 16 ]. The biotechnology industry and the products are regulated by various government organizations such as the US Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the US Department of Agriculture (USDA).

Medical Biotechnology

This fieldof biotechnology has many applications and is involved in production of recombinant pharmaceuticals, tissue engineering products, regenerative medicines such as stem cell and gene therapy, and many more biotechnology products for better human life (Fig. 1.6 ). Biotechnological tools produce purified bio-therapeutic agents on industrial scales. These include both novel agents and agents formerly available only in small quantities. Crude vaccines were used in antiquity in China, India, and Persia. For example, vaccination with scabs that contained the smallpox virus was a practice in the East for centuries. In 1798 English country doctor Edward Jenner demonstrated that inoculation with pus from sores due to infection by a related cowpox virus could prevent smallpox far less dangerously. It marked the beginning of vaccination. Humans have been benefited incalculably from the implementation of vaccination programs.

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Various applications of medical biotechnology

Tremendous progress has been made since the early recombinant DNA technology (RDT) experiments from which the lively—and highly profitable—biotechnology industry emerged. RDT has fomented multiple revolutions in medicine. Safe and improved drugs, accelerated drug discovery, better diagnostic and quick methods for detecting an infection either active or latent, development of new and safe vaccines, and completely novel classes of therapeutics and other medical applications are added feathers in its cap. The technology has revolutionized understanding of diseases as diverse as cystic fibrosis and cancer. Pharmaceutical biotechnology being one of the important sectors involves using animals or hybrids of tumor cells or leukocytes or cells ( prokaryotic, mammalian) to produce safer, more efficacious, and cost-effective versions of conventionally produced biopharmaceuticals. The launch of the new biopharmaceutical or drug requires screening and development. Mice were widely used as research animals for screening. However, in the wake of animal protection, animal cell culture offers accurate and inexpensive source of cells for drug screening and efficacy testing. Pharmaceutical biotechnology’s greatest potential lies in gene therapy and stem cell-based therapy. The underlying cause of defect of many inherited diseases is now located and characterized. Gene therapy is the insertion of the functional gene in place of defective gene into cells to prevent, control, or cure disease. It also involves addition of genes for pro-drug or cytokines to eliminate or suppress the growth of the tumors in cancer treatment.

But the progress so far is viewed by many scientists as only a beginning. They believe that, in the not-so-distant future, the refinement of “targeted therapies” should dramatically improve drug safety and efficacy. The development of predictive technologies may lead to a new era in disease prevention, particularly in some of the world’s rapidly developing economies. Yet the risks cannot be ignored as new developments and discoveries pose new questions, particularly in areas as gene therapy, the ethics of stem cell research, and the misuse of genomic information.

Many bio-therapeutic agents in clinical use are biotech pharmaceuticals. Insulin was among the earliest recombinant drugs. Canadian physiologists Frederick Banting and Charles Best discovered and isolated insulin in 1921. In that time many patients diagnosed with diabetes died within a few years. In the mid-1960s, several groups reported synthesizing the hormone.

The first “bioengineered” drug, a recombinant form of human insulin, was approved by the US Food and Drug Administration (FDA) in 1982. Until then, insulin was obtained from a limited supply of beef or pork pancreas tissue. By inserting the human gene for insulininto bacteria, scientists were able to achieve lifesaving insulinproduction in large quantities. In the near future, patients with diabetes may be able to inhale insulin, eliminating the need for injections. Inhaled insulinproducts like Exubera® were approved by the USFDA; however, it was pulled out and other products like Technosphere® insulin (Afrezza®) are under investigation. They may provide relief from prandial insulin. Afrezza consists of a pre-meal insulinpowder loaded into a cartridge for oral inhalation.

Technosphere technology: The technology allows administration of therapeutics through pulmonary route which otherwise were required to be given as injections. These formulations have broad spectrum of physicochemical characteristics and are prepared with a diverse assortment of drugs with protein or small molecule which may be hydrobhobic or hydrophilic or anionic or cationic in nature. The technology can have its applicability not only through pulmonary route but also for other routes of administration including local lung delivery.

The first recombinant vaccine, approved in 1986, was produced by cloning a gene fragment from the hepatitis B virus into yeast (Merck’s Recombivax HB). The fragment was translated by the yeast’s genetic machinery into an antigenic protein. This was present on the surface of the virus that stimulates the immune response. This avoided the need to extract the antigen from the serum of people infected with hepatitis B.

The Food and Drug administration (FDA) approved more biotech drugs in 1997 than in the previous several years combined. The FDA has approved many recombinant drugs for human health conditions. These include AIDS, anemia, cancers (Kaposi’s sarcoma, leukemia, and colorectal, kidney, and ovarian cancers), certain circulatory problems, certain hereditary disorders (cystic fibrosis, familial hypercholesterolemia, Gaucher’s disease, hemophilia A, severe combined immunodeficiency disease, and Turner’s syndrome), diabetic foot ulcers, diphtheria, genital warts, hepatitis B, hepatitis C, human growth hormone deficiency, and multiple sclerosis. Today there are more than 100 recombinant drugs and vaccines. Because of their efficiency, safety, and relatively low cost, molecular diagnostic tests and recombinant vaccines may have particular relevance for combating long-standing diseases of developing countries, including leishmaniasis (a tropical infection causing fever and lesions) and malaria.

Stem cell research is very promising and holds tremendous potential to treat neurodegenerative disorders, spinal cord injuries, and other conditions related to organ or tissue loss.

DNA analysis is another powerful technique which compares DNA pattern [ 14 ] after performing RFLP and probing it by minisatellite repeat sequence between two or more individuals. Its modification, DNA profiling (process of matching the DNA profiles for STS markers in two or more individuals; see chapter 18), which utilizes multilocus PCR analysis of DNA of suspect and victims, is very powerful and is useful in criminal investigation, paternity disputes, and so many other legal issues. The analysis is very useful in criminal investigations and involves evaluation of DNA from samples of the hair, body fluids, or skin at a crime scene and comparison of these with those obtained from the suspects.

Improved Diagnostic and Therapeutic Capabilities

The sequencing of the human genome in 2003, has given scientists an incredibly rich “parts list” with which to better understand why and how disease happens. It has given added power to gene expression profiling, a method of monitoring expression of thousands of genes simultaneously on a glass slide called a microarray. This technique can predict the aggressiveness of cancer.

The development of monoclonal antibodies in 1975 led to a medical revolution. The body normally produces a wide range of antibodies—the immune system proteins—that defend our body and eliminate microorganisms and other foreign invaders. By fusing antibody-producing cells with myeloma cells, scientists were able to generate antibodies that would, like “magic bullets,” bind with specific targets including unique markers, called antigenic determinants ( epitopes), on the surfaces of inflammatory cells. When tagged with radioisotopes or other contrast agents, monoclonal antibodies can help in detecting the location of cancer cells, thereby improving the precision of surgery and radiation therapy and showing—within 48 h—whether a tumor is responding to chemotherapy.

The polymerase chain reaction, a method for amplifying tiny bits of DNA first described in the mid-1980s, has been crucial to the development of blood tests that can quickly determine exposure to the human immunodeficiency virus (HIV). Genetic testing currently is available for many rare monogenic disorders, such as hemophilia, Duchenne muscular dystrophy, sickle cell anemia, thalassemia, etc.

Another rapidly developing field is proteomics, which deals with analysis and identification of proteins. The analysis is done by two-dimensional gel electrophoresis of the sample and then performing mass spectrometric analysis for each individual protein. The technique may be helpful in detecting the disease-associated protein in the biological sample. They may indicate early signs of disease, even before symptoms appear. One such marker is C-reactive protein, an indicator of inflammatory changes in blood vessel walls that presage atherosclerosis.

Nanomedicine is a rapidly moving field. Scientists are developing a wide variety of nanoparticles and nanodevices, scarcely a millionth of an inch in diameter, to improve detection of cancer, boost immune responses, repair damaged tissue, and thwart atherosclerosis. The FDA has approved a paclitaxel albumin-stabilized nanoparticle formulation (Abraxane® for injectable suspension, made by Abraxis BioScience) for the treatment of metastatic adenocarcinoma of the pancreas. Nanoparticles are being explored in heart patients in the USA as a way to keep their heart arteries open following angioplasty.

Therapeutic proteins are those, which can replace the patients naturally occurring proteins, when levels of the natural proteins are low or absent due to the disease. High-throughput screening, conducted with sophisticated robotic and computer technologies, enables scientists to test tens of thousands of small molecules in a single day for their ability to bind to or modulate the activity of a “target,” such as a receptor for a neurotransmitter in the brain. The goal is to improve the speed and accuracy of therapeutic protein or potential drug discovery while lowering the cost and improving the safety of pharmaceuticals that make it to market.

Many of the molecules utilized for detection also have therapeutic potential too, for example, monoclonal antibodies. The monoclonal antibodies are approved for the treatment of many diseases as cancer, multiple sclerosis, and rheumatoid arthritis. They are currently being tested in patients as potential treatments for asthma, Crohn’s disease, and muscular dystrophy. As the antibodies may be efficiently targeted against a particular cell surface marker, thus they are used to deliver a lethal dose of toxic drug to cancer cells, avoiding collateral damage to nearby normal tissues.

Agricultural Biotechnology

The manhas made tremendous progress in crop improvement in terms of yield; still the ultimate production of crop is less than their full genetic potential. There are many reasons like environmental stresses (weather condition as rain, cold, frost), diseases, pests, and many other factors which reduce the ultimate desired yield affecting crop productivity. The efforts are going on to design crops which may be grown irrespective of their season or can be grown in frost or drought conditions for maximum utilization of land, which would ultimately affect crop productivity [ 24 ]. Agricultural biotechnology aims to introduce sustainable agriculturalpractices with best yield potential and minimal adverse effects on environment (Fig. 1.7 ). For example, combating pests was a major challenge. Thus, the gene from bacterium , the Bt gene, that functions as insect-resistant gene when inserted into crop plants like cotton, corn, and soybean helps prevent the invasion of pathogen, and the tool is called . This management is helpful in reducing usage of potentially dangerous pesticides on the crop. Not only the minimal or low usage of pesticides is beneficial for the crop but also the load of the polluting pesticides on environment is greatly reduced [ 24 ].

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Various applications of agricultural biotechnology

Resistance to Infectious Agents Through Genetic Engineering

  • The gene comes from the soil bacterium .
  • The gene produces crystal proteins called Cry proteins. More than 100 different variants of the Bt toxins have been identified which have different specificity to target insect lepidoptera. For eg., CryIa for butterflies and CRYIII for beetles.
  • These Cry proteins are toxic to larvae of insects like tobacco budworm, armyworm, and beetles.
  • The Cry proteins exist as an inactive protoxins.
  • These are converted into active toxin in alkaline pH of the gut upon solubilization when ingested by the insect.
  • After the toxin is activated, it binds to the surface of epithelial cells of midgut and creates pores causing swelling and lysis of cells leading to the death of the insect (larva).
  • The genes (cry genes) encoding this protein are isolated from the bacterium and incorporated into several crop plants like cotton, tomato, corn, rice, and soybean.

The proteins encoded by the following cry genes control the pest given against them:

  • Cry I Ac and cry II Ab control cotton bollworms.
  • Cry I Ab controls corn borer.
  • Cry III Ab controls Colorado potato beetle.
  • Cry III Bb controls corn rootworm.
  • A nematode infects tobacco plants and reduces their yield.
  • The specific genes (in the form of cDNA) from the parasite are introduced into the plant using -mediated transformation.
  • The genes are introduced in such a way that both sense/coding RNA and antisense RNA (complimentary to the sense/coding RNA) are produced.
  • Since these two RNAs are complementary, they form a double-stranded RNA (ds RNA).
  • This neutralizes the specific RNA of the nematode, by a process called RNA – interference.
  • As a result, the parasite cannot multiply in the transgenic host, and the transgenic plantis protected from the pest.

These resistant crops result in reduced application of pesticides. The yield is high without the pathogen infestations and insecticides. This also helps to reduce load of these toxic chemicals in the environment.

The transformation techniques and their applications are being utilized to develop rice, cassava, and tomato, free of viral diseases by “International Laboratory for Tropical Agricultural Biotechnology” (ILTAB). ILTAB in 1995 reported the first transfer of a resistance gene from a wild-type species of rice to a susceptible cultivated rice variety. The transferred gene expressed and imparted resistance to crop-destroying bacterium Xanthomonas oryzae . The resistant gene was transferred into susceptible rice varieties that are cultivated on more than 24 million hectares around the world [ 6 ].

The recombinant DNA technology reduces the time between the identification of a particular gene to its application for betterment of crops by skipping the labor-intensive and time-consuming conventional breeding [ 3 ]. For example, the alteration of known gene in plant for the improvement of yield or tolerance to adverse environmental conditions or resistance to insect in one generation and its inheritance to further generations. Plant cell and tissue culture techniques are one of the applications where virus-free plants can be grown and multiplied irrespective of their season on large scale (micropropogation), raising haploids, or embryo rescue. It also opens an opportunity to cross two manipulated varieties or two incompatible varieties (protoplast culture) for obtaining best variety for cultivation.

With the help of technology, new, improved, and safe agricultural products may emerge which would be helpful for maintaining contamination-free environment. Biotechnology has the potential to produce:

  • High crop yields [ 4 ]
  • Crops are engineered to have desirable nutrients and better taste (e.g., tomatoes and other edible crops with increased levels of vitamin C, vitamin E, and/or beta-carotene protect against the risk of some prevalent chronic diseases and rice with increased iron levels protects against anemia)
  • Insect- and disease-resistant plants
  • Genetic modification avoids nonselective changes
  • Longer shelf life of fruits and vegetables

The potential of biotechnology may contribute to increasing agricultural, food, and feed production, protecting the environment, mitigating pollution, sustaining agricultural practices, and improving human and animal health. Some agricultural crops as corn and marine organisms can be potential alternative for biofuel production. The by-products of the process may be processed to produce other chemical feedstocks for various products. It is estimated that the world’s chemical and fuel demand could be supplied by such renewable resources in the first half of the next century [ 5 ].

Food Biotechnology

Food biotechnology is an emerging field, which can increase the production of food, improving its nutritional content and improving the taste of the food. The food is safe and beneficial as it needs fewer pesticides and insecticides. The technology aims to produce foods which have more flavors, contain more vitamins and minerals, and absorb less fat when cooked. Food biotechnology may remove allergens and toxic components from foods, for their better utility [ 6 , 7 ].

Environmental Biotechnology

Environmental biotechnology grossly deals with maintenanceof environment, which is pollution-free, the water is contamination-free, and the atmosphere is free of toxic gases. Thus, it deals with waste treatment, monitoring of environmental changes, and pollution prevention. Bioremediation in which utilization of higher living organisms (plants: phytoremediation) or certain microbial species for decontamination or conversion of harmful products is done is the main application of environmental biotechnology. The enzyme bioreactors are also being developed which would pretreat some industrial and food waste components and allow their removal through the sewage system rather than through solid waste disposal mechanisms. The production of biofuel from waste can solve the fuel crisis (biogas). Microbes may be engineered to produce enzymes required for conversion of plant and vegetable materials into building blocks for biodegradable plastics. In some cases, the by-products of the pollution-fighting microorganisms are themselves useful. For example, methane can be derived from a form of bacteria that degrades sulfur liquor, a waste product of paper manufacturing. This methane thus obtained is used as a fuel or in other industrial processes. Insect- and pest-resistant crops have reduced the use and environmental load of insecticides and pesticides. Insect-protected crops allow for less potential exposure of farmers and groundwater to chemical residues while providing farmers with season-long control.

Industrial Biotechnology

The utilizationof biotechnological tools (bioprocessing) for the manufacturing of biotechnology-derived products (fuels, plastics, enzymes, chemicals, and many more compounds) on industrial scale is industrial biotechnology. The aim is to develop newer industrial manufacturing processes and products, which are economical and better than preexisting ones with minimal environmental impact. In industrial biotechnology, (1) microorganisms are being explored for producing material goods like fermentation products as cheese; (2) biorefineries where oils, sugars, and biomass may be converted into biofuels, bioplastics, and biopolymers; (3) and value-added chemicals from biomass. The utilization of modern techniques can improve the efficiency and reduces the environmental impacts of industrial processes like textile, paper, pulp, and chemical manufacturing. For example, development and usage of biocatalysts, such as enzymes, to synthesize chemicals and development of antibiotics and better tasting liquors and their usage in food industry have provided safe and effective processing for sustainable productions. Biotechnological tools in the textile industry are utilized for the finishing of fabrics and garments. Biotechnology also produces spider silk and biotech-derived cotton that is warmer and stronger and has improved dye uptake and retention, enhanced absorbency, and wrinkle and shrink resistance.

Biofuels may be derived from photosynthetic organisms, which capture solar energy, transform it in other products like carbohydrates and oils, and store them. Different plants can be used for fuel production:

  • Bioethanol can be obtained from sugar (as sugarcane or sugar beet) or starch (like corn or maize). These are fermented to produce ethanol, a liquid fuel commonly used for transportation.
  • Biodiesel can be obtained from natural oils from plants like oil palm, soybean, or algae. They can be burned directly in a diesel engine or a furnace, or blended with petroleum, to produce fuels such as biodiesel.
  • Wood and its by-products can be converted into liquid biofuels, such as methanol or ethanol, or into wood gas. Wood can also be burned as solid fuel, like the irewood.

In these kinds of biological reaction, there are many renewable chemicals of economic importance coproduced as side streams of bioenergy and biofuels as levulinic acid, itaconic acid, and sorbitol. These have tremendous economic potential and their fruitful usage would depend upon the collaboration for research and development between the government and the private sector.

Enzyme Production

The enzymeshave big commercial and industrial significance. They have wide applications in food industry, leather industry, pharmaceuticals, chemicals, detergents, and research. In detergents the alkaline protease, subtilisin (from Bacillus subtilis ), was used by Novo Industries, Denmark. The production of enzymes is an important industrial application with world market of approximately 5 billion dollars. The enzymes can be obtained from animals, plants, or microorganisms. The production from microorganisms is preferred as they are easy to maintain in culture with simple media requirements and easy scale-up. The important enzymes for the industrial applications are in food industry, human application, and research. A few animal enzymes are also important as a group of proteolytic enzymes, for example, plasminogen activators, which act on inactive plasminogen and activate it to plasmin, which destroys fibrin network of blood clot. Some of the plasminogen activators are urokinase and tissue plasminogen activators (t-PA). Urokinase (from urine) is difficult to obtain in ample quantity; thus, t-PA is obtained from cells grown in culture medium. Streptokinase (bacterial enzyme) is also a plasminogen activator but is nonspecific and immunogenic.

Enzyme engineering is also being tried where modifications of specific amino acid residue are done for improving the enzyme properties. One of the enzymes chymosin (rennin) coagulates milk for cheese manufacturing.

The enzymes can be produced by culturing cells, growing them with appropriate substrates in culture conditions. After optimum time the enzymes may be obtained by cell disruption (enzymatic/freeze–thaw/osmotic shock) followed by preparative steps (centrifugation, filtration), purification, and analysis. The product is then packaged and ultimately launched in the market.

After their production, they can be immobilized on large range of materials (agar, cellulose, porous glass, or porous alumina) for subsequent reuse. Some of the important industrial enzymes are α-amylase (used for starch hydrolysis), amyloglucosidase (dextrin hydrolysis), β-galactosidase (lactose hydrolysis), aminoacylase (hydrolysis of acylated L-amino acids), glucose oxidase (oxidation of glucose), and luciferase (bioluminescence). Some of the medically important enzymes are urokinase and t-PA for blood clot removal and L-asparaginase for removal of L-asparagine essential for tumor growth and thus used for cancer chemotherapy in leukemia.

Exploring Algae for Production of Biofuels

The energyrequirement of present population is increasing and gradually fossil fuels are rapidly depleting. Thus, renewable energy sources like solar energy and wind-, hydro-, and biomass-based energy are being explored worldwide. One of the feedstocks may be microalgae, which are fast-growing, photosynthetic organisms requiring carbon dioxide, some nutrients, and water for its growth. They produce large amount of lipids and carbohydrates, which can be processed into different biofuels and commercially important coproducts. The production of biofuels using algal biomass is advantageous as they (1) can grow throughout the year and thus their productivity is higher than other oil seed crops, (2) have high tolerance to high carbon dioxide content, (3) utilize less water, (4) do not require herbicides or pesticides with high growth potential (waste water can be utilized for algal cultivation), (5) can sustain harsh atmospheric conditions, and (6) do not interfere with productivity of conventional crops as they do not require agricultural land. The production of various biofuels from algae is schematically represented in Fig. 1.8 .

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Different biofuel productions by using microalgae. The algae use sunlight, CO2, water, and some nutrients

Algae can serve as potential source for biofuel production; however, biomass production is low. The production has certain limitations, as cultivation cost is high with requirement of high energy [ 1 ].

Marine or Aquatic Biotechnology

Marine or aquatic biotechnology also referred to as “blue biotechnology” deals with exploring and utilizing the marine resources of the world. Aquatic or marine life has been intriguing and a source of livelihood for many since years. As major part of earth is acquired by water, thus nearly 75–80 % types of life forms exist in oceans and aquatic systems. It studies the wide diversity found in the structure and physiology of marine organisms. They are unique in their own ways and lack their equivalent on land. These organisms have been explored and utilized for numerous applications as searching new treatment for cancer or exploring other marine resources, because of which the field is gradually gaining momentum and economic opportunities [ 19 ]. The global economic benefits are estimated to be very high. The field aims to:

  • Fulfill the increasing food supply needs
  • Identify and isolate important compounds which may benefit health of humans
  • Manipulate the existing traits in sea animals for their improvement
  • Protect marine ecosystem and gain knowledge about the geochemical processes occurring in oceans

Some of the major applications are discussed:

  • Aquaculture: Aquaculture refers to the growth of aquatic organisms in culture condition for commercial purposes. These animals may be shellfish, finfish, and many others. Mariculture refers to the cultivation of marine animals. Their main applications are in food, food ingredients, pharmaceuticals, and fuels, the products are in high demand, and various industries are in aquaculture business, for example, crawfish farming (Louisiana), catfish industry (Alabama and Mississippi Delta), and trout farming (Idaho and West Virginia).
  • Transgenic species of salmon with growth hormone gene has accelerated growth of salmons.
  • Molt-inhibiting (MIH) from blue crabs leads to soft-shelled crab.
  • : Anovel protein antifreeze protein (AFP) was identified. AFPs were isolated from Northern cod (bottom-dwelling fish) living at the Eastern Canada coast and teleosts living in extremely cold weather of Antarctica. AFPs have been isolated from Osmerus mordax (smelt), Clupea harengus (herring), Pleuronectes americanus (winter flounder), and many others. Due to antifreeze properties (lowering the minimal freezing temperature by 2–3 °C), the gene has potential for raising plants which are cold tolerant (e.g., tomatoes).
  • Medicinal applications : For osteoporosis, salmon calcitonin (calcitonin is thyroid hormone promoting calcium uptake and bone calcification) with 20 times higher bioactivity is available as injection and nasal spray.
  • Hydroxyapatite ( HA ): Obtained from coral reefs and is an important component of bone and cartilage matrix. Its implants are prepared by Interpore Internationals which may be used for filling gaps in fractured bones.

Many anti-inflammatory, analgesic, anticancerous compounds have been identified from sea organisms which can have tremendous potential for human health.

Tetrodotoxin (TTX) is the most toxic poison (10,000 times more lethal than cyanide) produced by Japanese pufferfish or blowfish ( Fugu rubripes ). TTX is being used to study and understand its effect on sodium channels which can help guide the development of drugs with anesthetic and analgesic properties.

Other Products

  • Taq polymerase from Thermus aquaticus which is used in PCR reactions and obtained from hot spring Archaea.
  • Collagenase (protease) obtained from Vibrio is used in tissue engineering and culturing.

Transgenic Animals and Plants

In the early1980s, inserting DNA from humans into mice and other animals became possible. The animals and plants which have foreign gene in each of their cells are referred to as transgenic organisms and the inserted gene as transgene. Expression of human genes in these transgenic animals can be useful in studies, as models for the development of diabetes, atherosclerosis, and Alzheimer’s disease. They also can generate large quantities of potentially therapeutic human proteins. Transgenic plants also offer many economic, safe, and practical solutions for production of variety of biopharmaceuticals. The plants have been engineered to produce many blood products (human serum albumin, cytokines), human growth hormone, recombinant antibodies, and subunitvaccines.

The usage of transgenic plants for the production of recombinant pharmaceuticals might open new avenues in biotechnology. As plants can be grown inexpensively with minimal complicated requirements, thus they may have tremendous therapeutic potential. The plants have been engineered to produce more nutrients or better shelf life. The transgenic plants have been created which have genes for insect resistance (Bt cotton, soybean, corn). Now billion acres of land is used for cultivation of genetically engineered crops of cotton, corn, and soybean as they have higher yield and are pest resistant. However, due to social, ethical, and biosafety issues, they have received acceptance as well as rejections at many places and health and environment-related concerns in many parts of the world [ 8 ].

Response to Antibiotic Resistance

Antibiotics areone of the broadly used therapeutic molecules produced by certain classes of microorganisms (bacteria and fungi) which can be used in diverse clinical situations to eliminate bacteria, improve symptoms, and prevent number of infections. Antibiotics have various other applications apart from clinical aspects. They can be used for the treatment of tumors and treatment of meat, in cattles and livestocks, in basic biotechnological work. However, their effectiveness is a matter of concern as bacteria which are continuously exposed to certain antibiotics might become resistant to it due to accumulation of mutations. These days antibiotic-resistant bacteria have increased and some of them have developed multiple drug resistance. Thus, it has become very difficult to initiate therapy in diseases like tuberculosis and leprosy. Biotechnology is solving the urgent and growing problem of antibiotic resistance. With the help of bioinformatics—powerful computer programs capable of analyzing billions of bits of genomicsequence data—scientists are cracking the genetic codes of bacteria and discovering “weak spots” vulnerable to attack by compounds identified via high-throughput screening. This kind of work led in 2000 to the approval of Zyvox (linezolid), an antibiotic to reach the market in 35 years.

Lytic bacteriophage viruses that infect and kill bacteria may be another way to counter resistance. First used to treat infection in the 1920s, “phage therapy” was largely eclipsed by the development of antibiotics. However, researchers in the former Soviet Republic of Georgia reported that a biodegradable polymer impregnated with bacteriophages and the antibiotic Cipro successfully healed wounds infected with a drug-resistant bacterium.

After exposure of strontium-90, three Georgian lumberjacks from village Lia had systemic effects, and two of them developed severe local radiation injuries which subsequently became infected with Staphylococcus aureus . Upon hospitalization, the patients were treated with various medications, including antibiotics and topical ointments; however, wound healing was only moderately successful, and their S. aureus infection could not be eliminated. Approximately 1 month after hospitalization, treatment with PhagoBioDerm (a wound-healing preparation consisting of a biodegradable polymer impregnated with ciprofloxacin and bacteriophages) was initiated. Purulent drainage stopped within 2–7 days. Clinical improvement was associated with rapid (7 days) elimination of the etiologic agent, and a strain of S. aureus responsible for infection was resistant to many antibiotics (including ciprofloxacin) but was susceptible to the bacteriophages contained in the PhagoBioDerm preparation [ 11 ].

The Challenges for the Technology

Gene therapy.

Some biotechapproaches to better health have proven to be more challenging than others. An example is gene transfer, where the defective gene is replaced with a normally functioning one. The normal gene is delivered to target tissues in most cases by virus that is genetically altered to render it harmless. The first ex vivo gene transfer experiment, conducted in 1990 at the National Institutes of Health (NIH), on Ashanti DeSilva who was suffering from severe combined immunodeficiency (SCID) helped boost her immune response and successfully corrected an enzyme deficiency. However, treatment was required every few months. However, 9 years later, a major setback occurred in gene therapy trial after the death of 18-year-old Jesse Gelsinger suffering from ornithine transcarbamylase (OTC) deficiency due to intense inflammatory responses followed by gene therapy treatment. There were some positive experiences and some setbacks from gene therapy trials leading to stricter safety requirements in clinical trials.

Designer Babies

The fancyterm designer baby was invented by media. Many people in society prefer embryos with better traits, intellect, and intelligence. They want to select embryo post germline engineering. This technique is still in infancy but is capable of creating lot of differences in the society thus requires appropriate guidelines.

Genetically Modified Food

Genetically modifiedcrops harboring genes for insect resistance were grown on billion of acres of land. These crops became very popular due to high yield and pest resistance. However, some of the pests gradually developed resistance for a few of these transgenic crops posing resistant pest threat. The other technologies as “traitor” and “terminator” technologies pose serious risk on crop biodiversity and would impart negative characters in the crop (they were not released due to public outcry).

Pharmacogenomics

Scientists do not believe they will find a single gene for every disease. As a result, they are studyingrelationships between genes and probing populations for variations in the genetic code, called single nucleotide polymorphisms, or SNPs, that may increase one’s risk for a particular disease or determine one’s response to a given medication. This powerful ability to assign risk and response to genetic variations is fueling the movement toward “individualized medicine.” The goal is prevention, earlier diagnosis, and more effective therapy by prescribing interventions that match patients’ particular genetic characteristics.

Tissue Engineering

Tissue engineering is one of the emerging fields with tremendous potential to supply replacement tissue and organ option for many diseases. Lot is achieved, lot more need to be achieved.

Ethical Issues

The pursuit of cutting-edge research “brings us closer to our ultimate goal of eliminating disability and disease through the best care which modern medicine can provide.” Understanding of the genetics of heart disease and cancer will aid the development of screening tools and interventions that can help prevent the spread of these devastating disorders into the world’s most rapidly developing economies.

Biotechnology is a neutral tool; nevertheless, its capabilities raise troubling ethical questions. Should prospective parents be allowed to “engineer” the physical characteristics of their embryos? Should science tinker with the human germ line, or would that alter in profound and irrevocable ways what it means to be human?

More immediately, shouldn’t researchers apply biotechnology—if they can—to eliminate health disparities among racial and ethnic groups? While genetic variation is one of many factors contributing to differences in health outcome (others include environment, socioeconomic status, health-care access, stress, and behavior), the growing ability to mine DNA databases from diverse populations should enable scientists to parse the roles these and other factors play.

Biotechnology along with supportive health-care infrastructure can solve complicated health problems. Accessibility to the new screening tests, vaccines, and medications and cultural, economic, and political barriers to change must be overcome. Research must include more people from disadvantaged groups, which will require overcoming long-held concerns, some of them have had about medical science.

Biotechnology has been a significant force which has improved the quality of lives and has incalculably benefitted human beings. However, technology does have prospects of doing harm also due to unanticipated consequences. Each technology is subjected to ethical assessment and requires a different ethical approach. Obviously the changes are necessary as technology can have major impact on the world; thus, a righteous approach should be followed. There is uncertainty in predicting consequences, as this powerful technology has potential to manipulate humans themselves. Ethical concerns are even more important as the future of humanity can change which require careful attention and consideration. Therefore, wisdom is required to articulate our responsibilities toward environment, animals, nature, and ourselves for the coming future generations. We need to differentiate what is important technologically rather that what technology can do. For an imperative question, that is, whether this can be achieved, the research must answer “Why should it be achieved”? Who would it benefit?

Issues Related to Safety

  • As the new GM crops are entering the market, the issue regarding their consumption, whether they are safe, without any risk, is one of the important concerns [ 2 ]. Though the results related to safety and usage are well reported (as compared to conventional crops), unknown fear from these products makes them non acceptable at many places [ 20 ].
  • As insect- and pest-resistant varieties are being prepared and used as Bt genes in corn and cotton crops, there exists a risk of development of resistance insect population. Another important factor is that these resistant crops may harm other species like birds and butterfly.
  • The development of more weeds may occur as cross-pollination might result in production of weeds with herbicide resistance which would be difficult to control.
  • The gene transfers might cross the natural species boundary and affect biological diversity.
  • The judgment of their usage would depend upon the clear understanding of risks associated with safety of these products in determining the impact of these on environment, other crops, and other animal species.

Future of the Technology

With the understanding of science, we should understand that genetic transfers have been occurring in animals and plant systems; thus, the risk of the biotechnology-derived products is similar as conventional crops [ 12 ].

The biotechnology products would be acceptable to many if they are beneficial and safe. People are willing to buy crops free of pesticides and insecticides. Nowadays people are also accepting crops grown without the usage of chemical fertilizers or pesticides, which are high in nutritive values.

The labeling of the product is also an ethical issue as some believe that labeling any product as biotechnology product might be taken by consumer as warning signs; however, others believe that labeling should be done as consumer has every right to know what he is consuming [ 9 ]. The products may be acceptable if consumers can accept the food derived from biotechnology weighing all pros and cons and, if the price is right, has more nutritive values, is good in taste, and is safe to consume [ 10 ].

Biotechnology is at the crossroads in terms of fears and thus public acceptance [ 15 ]. Surprisingly the therapeutic products are all accepted and find major place in biopharmaceutical industry, but food crops are still facing problems in worldwide acceptance. The future of the world food supply depends upon how well scientists, government, and the food industry are able to communicate with consumers about the benefits and safety of the technology [ 13 , 16 ]. Several major initiatives are under way to strengthen the regulatory process and to communicate more effectively with consumers by conducting educational programs [ 18 , 23 ].

Chapter End Summary

  • The advantages of biotechnology are so broad that it is finding its place in virtually every industry. It has applications in areas as diverse as pharmaceuticals, diagnostics, textiles, aquaculture, forestry, chemicals, household products, environmental cleanup, food processing, and forensics to name a few.
  • Biotechnology is enabling these industries to make new or better products, often with greater speed, efficiency, and flexibility.
  • With the applications of recombinant DNA technology, more safer and therapeutic drugs are produced. These recombinant products do not elicit unwanted immunological response which is observed when the product is obtained from other live or dead sources. Many of these therapeutics are approved for human usage, and many of them are in the phase of development.
  • Immunological and DNA-based techniques like PCR (polymerase chain reaction) are used for early diagnosis of disorders. PCR and NAAT with microarray can be utilized for the diagnosis of many diseases, and it can detect mutations in gene.
  • The technology holds promise through stem cell research and gene therapy and holds applications in forensic medicine.
  • The technique may be helpful in developing useful and beneficial plants. It overcomes the limitations of traditional plant breeding. The techniques of plant tissue culture, transgenics, and marker-assisted selections are largely used for selecting better yielding varieties and imparting quality traits in plants.
  • Food industries. Production of single-cell protein, spirulina, enzymes, and solid-state fermentations
  • Increase and improvement of agricultural production
  • Production of therapeutic pharmaceuticals
  • Production of vaccines and monoclonal antibodies
  • Cultivation of virus for vaccine production

Multiple Choice Questions

  • All of the above
  • Vitamin D and calcium
  • Growth hormone
  • Tissue plasminogen activator
  • Factor VIII
  • Genetically modifying organism
  • Production of therapeutics
  • Production of better diagnosis
  • Increase in yield of crops
  • Improved crop varieties
  • Lesser fertilizers and agrochemicals
  • All of these
  • It is resistant to it.
  • The toxin is enclosed in vesicle.
  • The toxin is present in inactive form.
  • None of these.
  • Gene therapy
  • Replacement protein therapy
  • Stem cell therapy
  • The productivity would improve.
  • The usage of chemical agent would be reduced.
  • The environment and crop would be insecticide free.
  • All of the above.
  • Detoxifying waste material
  • Burying waste material
  • Burning waste material
  • None of these

(1) In all the cells of our body, all the genes are active.

(2) In different cells of our body, different genes are active.

(3) Gene expression is spatially and temporally regulated.

  • All 1, 2, and 3 are correct.
  • 1 and 2 are correct.
  • 1 and 3 are correct.
  • 2 and 3 are correct.
  • Inoculation with monoclonal antibody was able to prevent small pox.
  • Inoculation with pus from sores due to cowpox could prevent small pox.
  • Attenuated vaccine was able to prevent small pox.
  • None of the above.
  • 1. (c); 2. (a); 3. (c); 4. (d); 5. (d); 6. (d); 7. (c); 8. (a); 9. (d); 10. (a); 11. (d); 12. (b)

Review Questions

  • Q1. What are cry proteins? What is their importance?
  • Q2. Give some applications of biotechnology in agriculture.
  • Q3. What is your opinion about labeling of biotechnology-based food product as rDNA technology derived product?
  • Q4. What are applications of biotechnology in maintaining environment?
  • Q5. What is medical biotechnology?
  • Q6. What are the challenges faced by biotechnology industry?
  • Q7. What do you think about GM crops?

Some Related Resources

  • http://ificinfo.health.org/backgrnd/BKGR14.htm
  • http://www.bio.org/aboutbio/guide1.html
  • http://www.bio.org/aboutbio/guide2000/guide00_toc.html
  • http://www.bio.org/aboutbio/guide3.html
  • http://www.bio.org/aboutbio/guide4.html
  • http://www.dec.ny.gov/energy/44157.html
  • http://www.ers.usda.gov/whatsnew/issues/biotech/define.htm
  • http://www.nal.usda.gov/bic/bio21
  • http://www.nature.com/nbt/press_release/nbt1199.html
  • www.angelfire.com/scary/intern/links.html
  • www.bio-link.org/library.htm
  • www.biospace.com
  • www.dnai.org
  • www.fiercebiotech.com
  • www.iastate.edu
  • www.icgeb.trieste.it
  • www.ncbi.nlm.nih.gov

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medical biotechnology essay

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Medical Biotechnology: Advancement and Ethics

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medical biotechnology essay

What is Medical Biotechnology?

Medical biotechnology is a branch of medicine that uses living cells and cell materials to research and then produce pharmaceutical and diagnosing products. These products help treat and prevent diseases. From the Ebola vaccine to mapping human DNA to agricultural impacts, medical biotechnology is making huge advancements and helping millions of people.

Some of the most recent uses of biological tech is work in genetic testing, drug treatments, and artificial tissue growth. With the many advancements in medical biotechnology, there are new concerns that arise. From funding to ethics, there are many things to determine and regulate when it comes to this fast-paced industry. Learn about the many technical biology advancements and the concerns surrounding them.

Major Medical Biotechnology Advancements

From cancer research to agriculture advancements, medical biotechnology has many promising avenues of technological growth that have the potential to help many people.

CRISPR technology or CRISPR-Cas9 utilizes a protein called Cas9, which acts like a pair of molecular scissors and can cut DNA. CRISPRs are specialized stretches of DNA and are used in medical biotechnology as a tool to edit genomes. This allows scientists to alter DNA and modify gene functions, often called genetic engineering. There are many applications, like correcting genetic defects, treating diseases, preventing the spread of diseases, improving crops, and more. But the science of altering genomes has many ethical concerns surrounding it. From the ability to mutate genes and the unknowns surrounding gene mutation, CRISPR is a controversial area of biomedical science. Some new studies even show that perhaps CRISPR technology can create tumors and cancer with DNA deletions that aren’t controlled or precise. Of course, pharmaceutical companies and other scientific organizations that develop and utilize CRISPR technology are trying to downplay the concerns and issues, so the reality of the benefits and damage of the technology is somewhat unknown.

Tissue Nanotransfection

New science may have the ability to heal people with a single touch.  Sound too good to be true? It’s not. Tissue nanotransfection works by injecting genetic code into skin cells, which turns those skin cells into the other types of cells required for treating diseases. In some lab tests, one touch of TNT completely repaired the injured legs of mice over a period of a few weeks by turning skin cells into vascular cells. And reportedly, this biotech can work on other types of tissue besides skin. The potential for this type of gene therapy is huge, from helping car crash victims to active duty soldiers. Medical biotechnology has made this advancement possible, and the continued research and testing will only help improve this tech and adopt it across hospitals and medical centers.

Recombinant DNA Technology

Recombinant DNA technology  is combining DNA molecules from two different species and then inserting that new DNA into a host organism. That host organism will produce new genetic combinations for medicine, agriculture, and industry. There are many examples of recombinant DNA technology being utilized, from biopharmaceuticals and diagnostics to energy applications like biofuel to agricultural biotechnology with modified fruits and veggies. The genetically modified products are able to perform better than the regular medicine or produce. Recombinant agriculture is able to be more pest resistant or weather resistant; recombinant medicine like insulin is able to better work with bodies, etc. Because of the many benefits that recombinant DNA holds for a variety of products, researchers are optimistic about the future it has within biosciences and in other industries as well.

Genetic Testing from 23andMe

Genetic and ancestry kits are popular these days, and they are beneficial for more than just helping people understand their genetics and heritage. New studies are showing that saliva kits are able to test for things like breast cancer by looking at gene mutations. Certain races are also more likely to inherit certain mutations or human diseases, and knowing what races make up your genetic material can help you be prepared. While 23andMe test results shouldn’t be a reason to make decisions about treatments, understanding your heritage and how that could impact your health is valuable. 23andMe is also authorized to analyze for a variety of diseases, including Parkinson’s and Alzheimer's.

HPV Vaccine

You’ve probably heard of the Human Papilloma Virus (HPV) and how it’s linked to cervical cancer—which is the second most lethal form of cancer for women, next to breast cancer. Statistics show that cervical cancer kills 275,000 women annually, which is why a vaccine for HPV is so important. The good news is there are now two vaccines on the market—Cervarix and Gardasil—that have been approved by the U.S. Food and Drug Administration for use in women from ages 9 to 26.

Stem Cell Research

Biotechnology plays a big part in supporting stem cell research, which supports the exploration of growing stem cells in a lab setting or in vitro. This could help in situations where patients may be suffering from a disease or disorder where implanting stem cells could help restore their vitality and give them a new lease on life. How does it work? Because stem cells can repeatedly divide and transform into other types of body cells, biotechnologists can learn how to work with their unique profiles to encourage growth of specific types of cells. Though research is ongoing, it’s reported that the results show hope for the future of this unique medical approach.

medical biotechnology essay

Medical and Ethical Issues of Biotechnology

While there are great advancements and positives to medical biotechnology, anything this fast-growing and powerful is bound to come with some concerns and issues. Medical biotechnology is a controversial medical topic, with medical ethical issues associated.

Risk to Human Life in Clinical Trials

A huge risk of medical biotechnology is its impact during clinical trials. Because it’s such new tech, people can and have gotten hurt—and even died—during trials of the technology. Because of these risks, extensive research should be performed before even thinking of introducing tech to human subjects, and those who are participating in a trial should be extremely aware of any and all possibilities. Unfortunately, the paradox is that many times people who are sick are willing to try new things for the chance to get cured. This means researchers and doctors have a huge ethical responsibility to truly outline for a patient what the costs may be and respect their ultimate decision.

High Cost May Exclude the Poor

While medical biotechnology has huge potential to make medicine more efficient and easy, what’s the cost? This technology is often hugely expensive compared to traditional treatments. There is an ongoing give and take about finding new medical advancements and the cost it takes to do research and then market the findings for purchase. There is also the concern that high costs of tech treatments can exclude an entire class of people from being able to utilize them. This is also a huge give and take, with science and medicine having a responsibility to help all patients—not just those who are wealthy enough to buy the best care.

Privacy Concerns

Privacy is an ongoing issue in our technology world, but reading someone’s DNA seems to be a giant privacy breach. Imagine a doctor looks at a young child’s DNA and finds out they are likely to develop a heart disease or terminal issue. Does their employer have the right to know that? Should this information impact their ability to get a house or insurance? HIPAA offers some protection, but as medical biotechnology continues to advance the ability to read genes, insurance companies, doctors, and governments will have to come up with new programs and privacy tactics to match all the new needs that will arise.

Some Groups Oppose Stem Cell Research

Medical biotechnology is kind of a hot-button political issue, with presidential candidates even being asked about their position. The idea of working with fetal tissue, or other tissue, to learn about regrowth conjures images of Frankenstein’s monster. Scientists and researchers have been cautioned multiple times to be ethical and moral when doing this research. For example, using human tissue for research can be seen as ethical, while using an embryo’s tissue can be seen as unethical because it can damage the embryo. It is still early in the stem-cell research process, but as technology and research continue to advance in that area, scientists will have to consider moral and ethical lines even more.

Bioterrorism is a National Concern

Medical biotechnology has been used for security measures to help prevent a large number of people from possible bioterrorism. But the development of these projects takes away funding and time from curing known diseases. It becomes a real question of how to divide resources among projects and knowing where the resources are most needed. It’s difficult because we don’t know if people will die from bioterrorism but with so many people being concerned, it seems like a worthwhile place to spend time and money.

Any way you look at it, there are a number of concerns when it comes to medical biotechnology, and as we continue to make advancements, these ethical considerations will have to be made.

medical biotechnology essay

Role of Nurses in the Biotechnology Industry

Nurses have an ongoing role in medical biotechnology because of their direct experience with patient care. Nurses are able to use their knowledge and experience in hospitals and clinics to understand and demonstrate how medicines and drugs would impact large populations. Beyond knowing the science, they have the human element that researchers sometimes lack. They are able to understand how a patient would respond to a potential treatment and can help researchers consider new approaches to technology and adoption practices.

Nurses who have leadership and management experience can also help support researchers by keeping them on track with goals and checkpoints, ensuring that projects are moving along smoothly and key information is being conveyed to management. In instances where patients are part of the research, nurses can gain deeper insights from patients about their experiences in trials and how they’ve been affected. By being fluent in medical terminology and having the ability to effectively connect with patients, nurses can help bridge the gap between the two worlds and share valuable information between patients and researchers.

Role of Healthcare Leaders in the Biotechnology Industry

Because the biotech industry is constantly shifting and changing, strong leadership is needed to help navigate those changes and support researchers in their work. This is where healthcare managers come in. With their experience in operational management, these leaders can assist with streamlining processes and addressing the needs of a variety of stakeholders, while their knowledge of data-driven decision making can support researchers crunching the numbers associated with their work. An understanding of financial management can keep projects on budget, while experience in healthcare information technology is also a valuable asset to the biotech world. And with a background in marketing, healthcare leaders can also be key in communicating findings, both internally and externally.

Medical biotechnology is a field that is exploding and along with its potential for saving lives, it raises some ethical questions. As the field continues to grow, people from all types of industries are going to be required to make decisions to help regulate this field.

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The Impact of Medical Biotechnology on Society: Vaccines Argumentative Essay

The improvement of the people’s quality of life is the main purpose of the world health organisations and institutions. Biomedical scientists along with doctors and authorities work to make the nations healthier.

Many products of the biotechnological research contribute to the improvement of the people’s health and increase of the life expectancy. Vaccines as the products of biotechnology are widely used today in medicine to predict a lot of severe diseases along with eliminating the diseases’ spread round the world.

The specifics of vaccines’ effects are based on the increase of the people’s immunity. From this point, vaccines can guarantee the prolonged effect and protect from infections and diseases’ development completely. Vaccines are important for the development of the healthy society in developed and developing countries because they help people predict and overcome severe and deadly diseases.

Vaccines are specific mixtures which contain weakened or killed bacteria or viruses, or parts of viruses depending on the type of a vaccine. Vaccines are developed to imitate the infection and stimulate the organism to produce specific antibodies which can fight this or that virus. When the organism overcomes the virus from the vaccine, the immune system develops the immunity against this type of viruses (Rappuoli et al. 2011).

As a result, the person’s body can successfully fight the further infections associated with the definite disease. In spite of the fact the principle of a vaccine’s work is rather simple, there are a lot of debates on the effectiveness and safety of vaccines. That is why, it is significant to pay attention to the role, importance, and potentials of using vaccines in medicine.

Focusing on the impact of vaccines on the individual health, it is necessary to pay attention to the fact that vaccines are more effective than any other types of medical prevention and treatment of diseases. The human organism develops his own immune system to protect the body from infections. That is why, vaccines are important to help people overcome the severe diseases without being infected.

Moreover, the stimulation of the immunity contributes to the whole improvement of the people’s health. The developed immunisation schedule provides people with the opportunity to protect people from the majority of infectious diseases, contributing also to decreasing the costs associated with treatment (Schuchat 2011).

The role of vaccination in coping with viruses and bacteria from which suffered the previous generations cannot be overestimated.

Nevertheless, it is also important to concentrate on the larger scope of vaccines’ effects on the global population’s health. Vaccination is the necessary measure to avoid a lot of infections spread in developing countries. From this perspective, vaccination is effective to reduce the rate of severe and incurable diseases not only in developed countries but also round the globe.

The focus on vaccination helped reduce the rates of infectious diseases in Asia, Africa, and Latin America. Some severe diseases which caused thousands of deaths decades ago can be discussed as preventive today because of the possibilities provided by the development of biotechnology (Lin et al. 2010).

Today, vaccination can be discussed as the only preventive measure which can help people cope with the spread of such diseases as hepatitis B, varicella, yellow fever, typhoid, cholera, encephalitis, and rabies. That is why, immunisation programmes supported by authorities and social organisations are the first step to increasing the quality of the people’s life globally.

Asia, Africa, and Latin America remain to be discussed as regions where the risks of infections are the highest. To eliminate the diseases’ rates and to cope with the problem not only at the local level but also at the global level, vaccination is chosen as the most effective measure. It is important to note that vaccination of the part of population can contribute to elimination of diseases among the whole community.

The only challenge which can prevent the effective realisation of immunisation programs is the necessity of repeated vaccinations. The negative reaction of many people in relation to the effects of vaccination depends on expecting the immediate results when vaccination can be realised in several steps to guarantee the best effect (Rappuoli et al. 2011).

However, the decrease in mortality in many developing countries should be explained with references to the positive effects of vaccination. From this point, it is possible to contribute to the improvement of the global population’s health with the help of using vaccines.

Immunisation of adults and children in the developed countries help prevent millions of infections, severe consequences of diseases, premature deaths, and people’s hospitalisation (Schuchat 2011).

The global immunisation programs are associated with demands of developing countries, but the majority of developed countries focus on vaccination as the measure to predict severe diseases and overcome the annually changed types of influenza infection. The main issue connected with immunisation programmes to predict influenza is the side effects and safety of vaccination.

In their article, Black and the group of researchers discuss the possible effects of vaccination which are not associated with the cases of influenza diseases. The researchers state that side effects are observed, but the immunity of vaccinated people also improves (Black et al. 2009). Moreover, all the discussed side effects and syndromes are caused by the individual peculiarities of the people’s health conditions.

The development of vaccination can not only change the characteristic features of the people’s life span but also facilitate the treatment of cancer and many chronic diseases of the infectious nature. According to Rappuoli and the group of researchers, the health of the further generations directly depends on the successes in the development of new vaccines (Rappuoli et al. 2011).

Thus, today the vaccine to prevent tumours is developed, but it is possible to observe only starting stages of the process. Nevertheless, the development of biotechnology along with the focus on development of vaccines can provide people with hope that such agents and diseases as tuberculo­sis and HIV will be prevented with the help of vaccines in the future (Rappuoli et al. 2011).

The future of medicine is closely associated with biotechnology because such products of biomedical sciences as vaccination are necessary to help people decrease the rates of mortality, eliminate severe and fatal diseases, and to improve the quality of the people’s life with references to increasing the life expectancy.

Vaccines work to stimulate the human immunity. As a result, people can fight viruses and bacteria with the help of their own bodies’ powers developing the immunity against the definite type of viruses or bacteria. That is why, vaccination can be discussed as the real method to assist developing countries to cope with the consequences of poverty and insanitary conditions.

Black, S, Eskola, J, Siegrist, C, & Halsey, N 2009, “Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines”, Lancet , vol. 374 no. 97, 2115-2122.

Lin, C, Nowalk, M, Toback, S, & Rousculp, M 2010, “Importance of vaccination habit and vaccine choice”, Vaccine , vol. 28 no. 10, 7706-7712.

Rappuoli, R, Mandl, C, Black, S, & Gregorio, E 2011, “Vaccines for the twenty-first century society”, Nature Reviews Immunology , vol. 4 no. 1, 1-8.

Schuchat, A 2011, “Human vaccines and their importance to public health”, Procedia in Vaccinology , vol. 5 no. 1, 120–126.

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AP®︎/College Biology

Course: ap®︎/college biology   >   unit 6.

  • Introduction to genetic engineering

Intro to biotechnology

  • DNA cloning and recombinant DNA
  • Overview: DNA cloning
  • Polymerase chain reaction (PCR)
  • Gel electrophoresis
  • DNA sequencing
  • Applications of DNA technologies
  • Biotechnology

Key points:

  • Biotechnology is the use of an organism, or a component of an organism or other biological system, to make a product or process.
  • Many forms of modern biotechnology rely on DNA technology.
  • DNA technology is the sequencing, analysis, and cutting-and-pasting of DNA.
  • Common forms of DNA technology include DNA sequencing , polymerase chain reaction , DNA cloning , and gel electrophoresis .
  • Biotechnology inventions can raise new practical concerns and ethical questions that must be addressed with informed input from all of society.

Introduction

What is biotechnology.

  • Beer brewing . In beer brewing, tiny fungi (yeasts) are introduced into a solution of malted barley sugar, which they busily metabolize through a process called fermentation. The by-product of the fermentation is the alcohol that’s found in beer. Here, we see an organism – the yeast – being used to make a product for human consumption.
  • Penicillin. The antibiotic penicillin is generated by certain molds. To make small amounts of penicillin for use in early clinical trials, researchers had to grow up to 500 ‍   liters of “mold juice” a week 1 ‍   . The process has since been improved for industrial production, with use of higher-producing mold strains and better culture conditions to increase yield 2 ‍   . Here, we see an organism (mold) being used to make a product for human use – in this case, an antibiotic to treat bacterial infections.
  • Gene therapy. Gene therapy is an emerging technique used to treat genetic disorders that are caused by a nonfunctional gene. It works by delivering the “missing” gene’s DNA to the cells of the body. For instance, in the genetic disorder cystic fibrosis, people lack function of a gene for a chloride channel produced in the lungs. In a recent gene therapy clinical trial, a copy of the functional gene was inserted into a circular DNA molecule called a plasmid and delivered to patients’ lung cells in spheres of membrane (in the form of a spray) 3 ‍   . In this example, biological components from different sources (a gene from humans, a plasmid originally from bacteria) were combined to make a new product that helped preserve lung function in cystic fibrosis patients.

What is DNA technology?

Examples of dna technologies.

  • DNA cloning. In DNA cloning , researchers “clone” – make many copies of – a DNA fragment of interest, such as a gene. In many cases, DNA cloning involves inserting a target gene into a circular DNA molecule called a plasmid. The plasmid can be replicated in bacteria, making many copies of the gene of interest. In some cases, the gene is also expressed in the bacteria, making a protein (such as the insulin used by diabetics). Insertion of a gene into a plasmid.
  • Polymerase chain reaction (PCR). Polymerase chain reaction is another widely used DNA manipulation technique, one with applications in almost every area of modern biology. PCR reactions produce many copies of a target DNA sequence starting from a piece of template DNA. This technique can be used to make many copies of DNA that is present in trace amounts (e.g., in a droplet of blood at a crime scene).
  • Gel electrophoresis. Gel electrophoresis is a technique used to visualize (directly see) DNA fragments. For instance, researchers can analyze the results of a PCR reaction by examining the DNA fragments it produces on a gel. Gel electrophoresis separates DNA fragments based on their size, and the fragments are stained with a dye so the researcher can see them. DNA fragments migrate through the gel from the negative to the positive electrode. After the gel has run, the fragments are separated by size, with the smallest ones near the bottom (positive electrode) and the largest ones near the top (negative electrode). Based on similar diagram in Reece et al. 5 ‍  
  • DNA sequencing. DNA sequencing involves determining the sequence of nucleotide bases (As, Ts, Cs, and Gs) in a DNA molecule. In some cases, just one piece of DNA is sequenced at a time, while in other cases, a large collection of DNA fragments (such as those from an entire genome) may be sequenced as a group. [What is a genome?]

Biotechnology raises new ethical questions

  • Some of these relate to privacy and non-discrimination. For instance should your health insurance company be able to charge you more if you have a gene variant that makes you likely to develop a disease? How would you feel if your school or employer had access to your genome?
  • Other questions relate to the safety, health effects, or ecological impacts of biotechnologies. For example, crops genetically engineered to make their own insecticide reduce the need for chemical spraying, but also raise concerns about plants escaping into the wild or interbreeding with local populations (potentially causing unintended ecological consequences).
  • Biotechnology may provide knowledge that creates hard dilemmas for individuals. For example, a couple may learn via prenatal testing that their fetus has a genetic disorder. Similarly, a person who has her genome sequenced for the sake of curiosity may learn that she is going to develop an incurable, late-onset genetic disease, such as Huntington's.

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How Medical Biotechnology Is Advancing Modern Healthcare

Man wearing business casual explains medical biotechnology product plans to colleagues on a large wall screen.

Advancements in medical biotechnology have impacted millions of lives in the past few decades.

From new vaccines developed to cure deadly diseases — such as during the Ebola virus outbreak in West Africa in 2014 — to comprehensively mapping human DNA, the medical biotechnological industry has been on the forefront of technological advancement.

Medical biotechnology is the use of living cells and cell materials to research and produce pharmaceutical and diagnostic products that help treat and prevent human diseases.

Some of the latest areas of medical biotechnological advancement include pioneering work in genetic testing, advanced drug treatments and artificial tissue growth.

Medical Biotechnical Applications

Stem cell treatments.

Each year, scientists and medical biotechnical researchers advance further into the field of stem cell research.

The world-famous Salk Institute, one of the leading nonprofit medical biotechnical organizations, created a new kind of stem cell in 2017, one that helped grow mice in a laboratory from an embryo to the adult stage.

The new cell type is called an “extended pluripotent stem cell,” which is the foundation of every cell in the body. Embryonic stem cells that come from human embryos or that are artificially created are unable to develop every type of cell the human body needs, which makes the EPS cell a special discovery.

In addition to creating muscle, blood, bone and tissue cells, among many others, the EPS cell can also make the placenta and “other extra-embryonic tissues needed for the embryo to survive and grow.”

Interested in Healthcare Administration?

As the healthcare field continues its rapid growth, now is a great time to take the next step in your healthcare position or make a move into the field.

Monoclonal Antibodies for Therapy

One of the most important advancements in medical biotechnology is the ability to use one’s own immune system to beat diseases.

Researchers began studying monoclonal antibodies in the 1970s, and now they are a standard treatment for serious illnesses. Monoclonal antibodies are lab-produced molecules “engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cancer cells.”

These antibodies can serve a number of functions, including flagging cancer cells for the immune system to fight, triggering cell-membrane destruction, blocking cell or blood vessel growth and blocking immune system inhibitors.

In general, monoclonal antibody treatment has fewer side effects than traditional chemotherapy treatments, making it a popular alternative to chemotherapy or as a parallel treatment.

Genome Sequencing

One of the current and future avenues of medical biotechnology is in genome sequencing.

In 1999, researchers were able to map the entire DNA sequence of human chromosome 22, the first time a human chromosome had been fully mapped. Since then, technology has advanced to the point that thousands of genomes have been fully or partially sequenced. Doctors can now anticipate whether certain diseases will be passed genetically from parents to children.

Although human genome research continues, the technology has entered the private market. Companies like 23 and Me or startups such as Helix, Veritas and Color provide the public with lab-produced genome sequencing tests to see discover ancestry information or whether individuals are susceptible to a heredity-linked diseases.

Gene-Therapy Drugs

The future of medical biotechnology is certainly intertwined with gene-therapy drugs.

The recent developments in gene therapy have offered hope to many suffering from genetic diseases that they can be cured. In December 2017, the U.S. Food and Drug Administration approved a new gene-therapy treatment for a rare, genetically inherited form of blindness.

The therapy, called Luxturna , is the first “directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.” The therapy works by delivering a normal copy of the RPE65 gene directly into retinal cells. This helps the cells produce the normal enzymes that help convert light into sight.

Looking ahead, the FDA recently approved CAR T-cell therapy for certain children and young adults with a type of acute lymphoblastic leukemia (ALL).

Medical Biotechnology Salary Expectations

It’s never been a better time to enter the medical biotechnology field, especially at the management and administrative levels. The U.S. Bureau of Labor Statistics estimates the field will grow by more than 20 percent through 2026 , adding more than 72,000 jobs to the workforce. And medical and health service managers earned median salaries of $96,540 per year.

Some potential management-level roles include director of clinical pharmacology, senior medical director, clinical research monitor and an administrative coordinator.

Pursue a Career in Healthcare Administration

As the healthcare field continues its rapid growth, now is a great time to take the next step in your healthcare position or make a move into the field. Let Campbellsville University help you achieve your professional goals with one of our fully online business degree programs that specialize in healthcare management.

Campbellsville offers both an online B.S. in Business Administration and an online MBA that equips you with the skills you need to become a leader in healthcare management. Take advantage of our fully online format, allowing you to balance your education with your busy life, while learning from faculty who have real-world knowledge and your success in mind.

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Essay on biotechnology and health care.

medical biotechnology essay

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In this essay we will discuss about use of Biotechnology in Health Care. After reading this essay you will learn about: 1. Introduction to Biotechnology in Health Care 2. Applications of Biotechnology in Health Care 3. Biopharmaceuticals 4. Cloning 5. Forensic Biotechnology 6. Human Genome Project 7. New Drug Delivery System 8. Role of Nanotechnology in Drug Delivery 9. Enhanced Nutritional Aspects and Other Details.

  • Essay on the Conclusion to Biotechnology in Health Care

Essay # 1. Introduction to Biotechnology in Health Care:

The histrionic rate of advancement in biotech­nology has brought about a widespread revolution in the health care system. The discov­eries in molecular biology, genomics, cellular and tissue engineering, new drug discovery and delivery techniques, and bio-imaging hold the promise of improving health care by en­hancing the diagnostic capabilities and substantially expanding therapeutic options.

Hence, there is emergence of therapies that have a lot less side effects, vaccines which are safer than ever before and innovative diagnos­tic aids that are faster and smaller in size with warranted accuracy. Over the past decade, the pace of biotechnological research has markedly accelerated, while the scope and expenditures for the biotechnology research enterprises have increased substantially.

It has effectively enabled the scientists, researchers and physi­cians to work at the cellular and molecular lev­els to produce major benefits to life sciences and healthcare. Today approximately, 418 new biotech medicines and vaccines are being tested for more than 100 diseases, among which 210 to treat cancer, 50 to treat infec­tious diseases and 44 to treat autoimmune dis­orders.

In the next few years, the emerging field of Nano biotechnology will lead to new biotechnological based industries and novel approaches in medical practice. Biotechnology have opened up new doors when it comes to researching and learning more about the hu­man body and thereby is the key to many prob­lems related to health and well-being of the human beings.

Essay # 2. Applications of Biotechnology in Health Care :

The medical application of biotechnology is often referred to as Red Biotechnology. Health care biotechnology uses chemistry of living organisms through molecular biology and cell manipulation to develop new or alternative methods in order to find more effective ways of producing traditional products.

Its integra­tion with nanotechnology, Nano-materials and information technology has led to the devel­opment of innovative and revolutionary appli­cations in health care. Nowadays health care Biotech products and techniques are being implemented in various areas of health care, including: biopharmaceuticals, drug delivery systems, diagnostic testing, tissue replace­ment, etc.

However, the realization of these applications immensely depend on variety of factors such as social and cultural acceptance of technological changes, infrastructure invest­ment in respective countries, market drivers and other structural determinants and the level of impact may also vary from developing and developed countries.

Essay # 3. Biopharmaceuticals:

In this modernized world, pharmaceutical products have become the backbone of medici­nal therapies. Bio pharmaceutics is the field of study concerning biopharmaceuticals that are nothing but medical drugs manufactured using biotechnology.

The term ‘biopharmaceutical’ was first introduced in the 1980s which precisely described a class of therapeutic pro­teins produced by modern biotechnological techniques. The large majority of biopharmaceutical products are pharmaceuticals that are derived from various life forms. Today approxi­mately one in every four new drug thus intro­duced in the market is a biopharmaceutical.

The majority of biopharmaceuticals thus ap­proved or in development stage are proteins based produced via genetic engineering which also encompass nucleic-acid-based, i.e., deoxy­ribonucleic acid (DNA) or ribonucleic acid(RNA)-based products, and whole-cell-based products.

Another potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. They can be used for thera­peutic or in vivo diagnostic purposes, and are produced by means other than direct extrac­tion from a native (non-engineered) biological source.

The products include a range of hor­mones, blood factors and thrombolytic agents, as well as vaccines monoclonal antibodies and protein based therapeutic agents. Most of the biopharmaceuticals approved till date are intended for human usage only.

The first such substance approved for thera­peutic use was recombinant human insulin. However, a number of products for veterinary application have also come on the market. One early such example is that of recombinant bo­vine GH (Somatotrophin), which was approved in the U.S.A. in the early 1990s and used to increase milk yields from dairy cattle.

medical biotechnology essay

1. It is a natural pathway to gear up the crea­tion of new class of innovative medicines that can be further designed to be highly potent for treating variety of diseases.

2. It is capable of targeting any given pro­tein thereby eliminating the key limitation of traditional medicines that can only tar­get certain classes of proteins.

3. It enables forthright identification of ap­propriate drug candidates using siRNAs that can be designed eventually to be ac­tive across a wide range of species.

4. It has the ability to selectively deplete a specific protein of interest in cultured cells using siRNAs, plasmids and viral vectors.

5. The timing and extent of the gene silenc­ing can be controlled. Hence, the essential genes can be silenced at any stages of growth and this approach provides a great degree of flexibility.

1. The direct introduction of chemically syn­thesized siRNAs into the cells is limited by the short-lived nature of their transient gene silencing effects and their relative instability.

2. Though a high degree of specificity is as­sociated with RNAi yet some effects have been observed that are independent of the specific gene targeted for silencing.

3. Nucleic acid-based gene-silencing mol­ecules may have effects on genes that are not considered targets and these off-tar- get effects are due to similarities in nucleic acid sequences.

4. The specificity of RNAi-mediated degrada­tion of homologous mRNA makes this strategy highly prone to the development of resistance, as simple changes in target sequences may make previously effective siRNA triggers absolutely impotent.

5. The targeting of proteins with a long half- life may result in therapeutic failure de­spite successful gene silencing, since si­lencing at the transcript level does not af­fect pre-existing proteins.

Role of miRNAIn Diseases Management :

A microRNA (miRNA) is a short ribonucleic acid (RNA) molecule found in eukaryotic cells. A microRNA molecule has very few nucleotides in comparison to that of other RNAs. miRNA is an essential factor in the normal function­ing of eukaryotic cells. On the other hand, dysregulation of miRNA has been associated with various diseases and conditions.

miRNA and Inherited Diseases :

A mutation in the seed region of miR-96 causes hereditary progressive hearing loss. A muta­tion in the seed region of miR-184 causes he­reditary keratoconus with anterior polar cata­ract. Simultaneously the deletion of the miR- 17-92 cluster causes skeletal and growth de­fects.

miRNA and Heart Disease :

The miRNA expression profiling studies dem­onstrate that expression levels of specific miRNAs change in diseased human hearts, pointing to their involvement in cardiomyopathies.

Further studies on specific miRNAs in animal models have identified distinct roles for miRNAs both in the development of heart and in pathological conditions, including the regulation of key factors important forcardiogenesis, the hypertrophic growth re­sponse, and cardiac conductance.

miRNA and the nervous system :

miRNAs appear to regulate the nervous sys­tem. Neural miRNAs are involved at various stages of synaptic development, including dendritogenesis (involving miR-132, miR-134 and miR-124), synapse formation and synapse maturation (where miR-134 and miR-138 are thought to be involved). Recent studies have also revealed altered miRNA expression in schizophrenia cases.

miRNA and Viruses :

The expression of transcription activators by human herpes virus-6 DNA is believed to be regulated by viral miRNA.

miRNA and Non-Coding RNAs :

When the human genome project mapped its first chromosome in 1999, it was predicted that genome would contain over 100,000 protein coding genes. However, only around 20,000 were eventually identified (International Hu­man Genome Sequencing Consortium, 2004).

Since then, the advent of bioinformatics ap­proaches combined with genome tiling stud­ies examining the transcriptome, systematic sequencing of full length cDNA libraries and experimental validation (including the creation of miRNA derived antisense oligonucleotides called antagomirs) have revealed that many transcripts are non-protein-coding RNA, in­cluding several snoRNAs and miRNAs.

miRNA and Cancer :

MicroRNAs can also act as oncogenes, directly and indirectly either by down-regulating tumour suppressors or by down-regulating genes that can act to restrict the activity of known oncogenes, Overexpression of these oncogenic miRNA may reduce protein products of tumour- suppressor genes.

On the other hand, loss of such tumour-suppressor miRNA expression may cause elevated levels of oncogenic protein. Several miRNAs have been found to have links with some types of cancer and are sometimes referred to as “oncomirs.” MicroRNA-21 was one of the first microRNAs to be identified as an oncomir.

A novel miRNA-profiling based screening assay for the detection of early-stage colorectal cancer has been developed and is currently in clinical trials. miRNA signatures may enable classification of various malignan­cies depending on their tissue of origin.

An­other role for miRNA in cancers is to use their expression level as a prognostic. The expand­ing knowledge of specific roles of certain microRNAs is further contributing to our un­derstanding of the complexity, progression and behaviour at molecular scale in oral cancer cases.

It is evident that the field of miRNAs and the study of the roles of miRNAs in oral can­cer and cancers in general, is at infant stage. Yet their potentiality as therapeutic tools in management of oral cancer cases has not gone unnoticed.

A promising approach is to target oncogenic miRNAs with oligonucleotides complementary for either their mature or pre­cursor sequence, often referred to as anti- miRNA oligonucleotides (AMOs). In future, implementation of the available information can further enhance our abilities to improve the outcome of the treatment modalities in cancer.

Essay # 17. Benefits of Health Care Biotechnology:

Health care biotech increases the effectiveness and safety parameters of treatments as well as immensely reduces the use of ineffective treatments and adverse reactions.

All of these bold technologies, and those that are still in the pipeline, promise a brighter future to the health care industry and the world with nume­rous benefits to their credit that are as follows:

A. Stability and compatibility of therapeutics

B. Minimizing localized and systemic reac­tions: broader implications

C. Expanding treatment options

D. The design of EFFICIENT diagnostic kits

E. The creation of genome analysis tools through bioinformatics

F. Molecular biology method to help under­stand the nature of diseases

G. Finding targets for drugs

H. Use of DNA fingerprinting in the court of law

I. Use of the PCR reaction to clone DNA and make millions of identical copies

K. Health care will shift from labour inten­sive (provider) to capital intensive (phar­maceuticals)

L. New drug development is a boon for aca­demic medical centres and clinical re­search organizations

M. Treating diseases efficiently will increase longevity of the human beings

N. May cut down the costs of drug develop­ment.

Essay # 18. Drawbacks of Health Care Biotechnology:

Drawbacks Associated with Heath Care Biotechnology :

Since time immemorial human beings have often shown the interest in manipulating nature, and much of the current state of the world is due to this ability. Due to our desire to de­velop nature to its utmost potential, many side effects of tampering with nature have been revealed.

When it comes to biotechnology, the possibilities of side effects can become alarm­ing along with the costs and morality issues. They also inspire caution which cannot be ig­nored either.

Biotech products are often more ex­pensive and less practical than alterna­tives.

Ethics-related concerns include cloning, xenotransplantation, stem cell research, fetal tissue use, and genetic modification of organisms that questions the morality of various such practices.

The problem with the legalities of various biotechnological practices is that there are few laws directly addressing many of the issues involved and much of the technology lay in uncharted territory.

D. Uncertainty:

The biggest concern over biotechnology is the uncertainty in its long term effects that is unclear and unpredict­able.

E. Unsuccessful Stories:

Numerous unwor­thy projects and unsuccessful applications might defer the determination of the sci­entists who aspire to make our future bright with vision biotech-healthcare.

Essay # 19. Conclusion to Biotechnology in Health Care :

Biotechnology is changing both the health care and its effective delivery in a profound way. No other industry is better placed to enhance quality of life and deal with the Challenges thus faced by the society of tackling an increas­ing population, health care choice, its affordability, resource efficiency, food security and environmental issues.

Health care biotech is already benefiting more than 350 million patients around the world through the use of biotech medicine to prevent and treat illnesses including heart attack, stroke, multiple scle­rosis, breast cancer, cystic fibrosis, leukemia, diabetes, hepatitis and other rare or infectious diseases.

It helps us to live healthier for a longer duration by providing us with enormous medical choices and solutions. Biotechnology has been used for more than 6,000 years for lots of interesting and practical purposes: mak­ing food such as bread and cheese, preserving dairy products and fermenting beer.

Although we do not always realize it, yet it is a huge part of our everyday lives, from the clothes we wear and how we wash them, the food we eat and the sources it comes from, the medicine we use to keep us healthy and even the fuel we use to take us where we need to go, biotech already plays, and must continue to play, an invaluable role in meeting our needs.

From new drugs that address our medical needs and fight epidemics and rare diseases, to industrial processes that use renewable feedstock instead of crude oil to lower the impact on the envi­ronment and crops that are able to grow in harsh climatic conditions and ensure safe and affordable food, biotech can and will pay eco­nomic, social and environmental dividends.

But for this to happen, the industry requires sound policy decisions that support innova­tions. At the same time it should be potent enough to generate a public awareness in the area of biotechnology. This will ultimately help in the creation of a healthier, greener, produc­tive and a sustainable economy.

Related Articles:

  • Biotechnology Boom May Have a Golden Path for India – Essay
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Volodymyr Zelenskiy at a press conference in Odesa.

Zelenskiy calls for operational changes to Ukraine military after sacking commander

President demands ‘new level of medical support for soldiers’ as questions mount over speed of counteroffensive against Russia

Volodymyr Zelenskiy has demanded rapid changes in the operations of Ukraine’s military and announced the dismissal of the commander of its medical forces.

The Ukrainian president’s move was announced on Sunday as he met defence minister, Rustem Umerov, and coincided with debate over the conduct of the 20-month-old war against Russia , with questions over how quickly a counteroffensive in the east and south is proceeding.

“In today’s meeting with defence minister Umerov, priorities were set,” Zelenskiy said in his nightly video address. “There is little time left to wait for results. Quick action is needed for forthcoming changes.”

Zelenskiy said he had replaced Maj Gen Tetiana Ostashchenko as commander of the medical forces.

“The task is clear, as has been repeatedly stressed in society, particularly among combat medics, we need a fundamentally new level of medical support for our soldiers,” he said.

This, he said, included a range of issues – better tourniquets, digitalisation and better communication.

Umerov acknowledged the change on the Telegram messaging app and set as top priorities digitalisation, “tactical medicine” and rotation of service personnel.

Ukraine’s military reports on what it describes as advances in recapturing occupied areas in the east and south and last week acknowledged that troops had taken control of areas on the eastern bank of the Dnipro River in southern Kherson region.

Ukrainian commander in chief, Gen Valery Zaluzhny, in an essay published this month, said the war was entering a new stage of attrition and Ukraine needed more sophisticated technology to counter the Russian military.

While repeatedly saying advances will take time, Zelenskiy has denied the war is headed into a stalemate and has called on Kyiv’s western partners, mainly the United States, to maintain levels of military support.

Ostashchenko was replaced by Maj Gen Anatoliy Kazmirchuk, head of a military clinic in Kyiv.

Her dismissal came a week after a Ukrainian news outlet suggested her removal, as well as that of others, was imminent after consultations with paramedics and other officials responsible for providing support to the military.

Meanwhile on Sunday, air defence units in Moscow intercepted a drone targeting the city, mayor Sergei Sobyanin said.

Sobyanin, writing on the Telegram messaging app, said units in the Elektrostal district in the capital’s east had intercepted the drone.

According to preliminary information, falling debris resulting from the operation had caused no casualties or damage, Sobyanin said.

  • Volodymyr Zelenskiy

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    Biotechnology is a rapidly changing field that continues to transform both in scope and impact. Karl Ereky first coined the term biotechnology in 1919. However, biotechnology's roots trace back to as early as the 1600s when a Prussian physician, Georg Ernst Stahl, pioneered a new fermentation technology referred to as "zymotechnology."

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    Biotechnology is the use of an organism, or a component of an organism or other biological system, to make a product or process. Many forms of modern biotechnology rely on DNA technology. DNA technology is the sequencing, analysis, and cutting-and-pasting of DNA. Common forms of DNA technology include DNA sequencing, polymerase chain reaction ...

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    Medical Biotechnology Salary Expectations. It's never been a better time to enter the medical biotechnology field, especially at the management and administrative levels. The U.S. Bureau of Labor Statistics estimates the field will grow by more than 20 percent through 2026, adding more than 72,000 jobs to the workforce. And medical and health ...

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    Essay, Pages 2 (439 words) Views. 4. Medical biotechnology has become an integral part of the economy because this industry has rapidly doubled in size within recent years. I am eager to gain an insight into key technical, business and societal issues which impact the developments in the biotechnological industries such as drug development ...

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