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Varsha gupta.
5 Institute of Biosciences and Biotechnology, Chhatrapati Shahu Ji Maharaj University, Kanpur, UP India
6 George Washington University, Washington DC, USA
7 Orthopaedics Unit, Community Health Centre, Kanpur, UP India
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.
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.
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.
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
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
Eukaryotic transcription | ||
---|---|---|
Transcription factor (TF) | Functions | |
TFIID | TATA binding | It recognizes |
Protein (TBP) | TATA box | |
Subunit | ||
TBP associated | Regulate DNA | |
Factors | Binding by TBP | |
TFIIB | Recognizes TFIIB recognition elements (BRE); positions RNA polymerase (RNA pol) | |
TFIIF | Stabilizes RNA pol; attracts TFIIE and TFIIF | |
TFIIE | Regulates TFIIH | |
TFIIH | Unwinds DNA at transcription start point; releases RNA polymerase from promoter |
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 ].
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).
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.
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.
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.
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 ].
Various applications of agricultural biotechnology
The proteins encoded by the following cry genes control the pest given against them:
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:
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 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 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.
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:
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.
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.
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 .
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 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:
Some of the major applications are discussed:
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.
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 ].
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 ].
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.
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 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).
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 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.
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?
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 ].
(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.
In surgical rooms, doctors can now operate on patients remotely from their computer screens, guiding robotic arms to an accuracy of a few nanometers. Genetic laboratories equipped with DNA splicing enzymes, a mere sequence of polypeptide chains, can make wonders happen. The entire genetic makeup of human beings can be deconstructed into understandable genetic codes. Medical biotechnology has moved forward by leaps and bounds in the last few decades.
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Stem cells can keep dividing infinitely and have the capacity to differentiate into different types of body cells during the early development of an organism. In a laboratory, researchers can program these stem cells to differentiate into specific types of cells. This is where the innovation of biotechnology steps in. Imagine an individual with the degenerative spinal disorder that severely impacts their quality-of-life. With the help of stem cell research, it might be possible to grow these stem cells in vitro , in a lab setting, and then implanted back into the affected individual’s body. This would help restore their cognitive acuity, vision, hearing, and other physical features. This may sound far-fetched and like a plot from a sci-fi movie, but the preliminary results have been promising.
Often lauded as the one of greatest feat of exploration in human history, the Human Genome Project (HGP) was an international scientific research project coordinated by the National Institutes of Health and the U.S. Department of Energy. It was officially launched in 1990 with the goal of determining the sequence of nucleotide base pairs that make up human DNA . In April 2003, the researchers announced that they had completed a preliminary sequencing of the entire human genome. This work of the HGP has allowed researchers to begin to understand the blueprint for building a person. As researchers learn more about the functions of genes and proteins, it has aided them in identifying genes that cause diseases.
Currently, established standard chemotherapies are toxic for healthy cells. Targeted cancer therapies are drugs that work either by interfering with the function of specific molecules or by only targeting known cancerous cells, in order to minimize damage to healthy cells. According to the National Cancer Institute, “Eventually, treatments may be individualized based on the unique set of molecular targets produced by the patient’s tumor.”
Surgery is brutal on a human body, and medical breakthroughs that make the surgical and healing process more efficient is always welcomed. Biotechnology has now made it possible for doctors to view an entire 3D image of the inside of a patient’s body through the use of MRI and CT scans. This allows each organ to be precisely projected so that the surgeon can make small, targeted incisions to minimize bodily trauma to the patient. Furthermore, augmented reality would allow pertinent information to be displayed directly overlaid over the relevant body parts.
Human Papilloma Virus (HPV) is one of the causative agents of cervical cancer. It is the second most lethal cancer in women, second only to breast cancer, killing 275,000 women worldwide every year. Therefore, a successful HPV vaccination is considered a major medical accomplishment. The U.S. Food and Drug Administration (FDA) has approved HPV vaccines like Gardasil and Cervarix for use among females between 9 – 26 years of age.
8. 3d printed organs.
Artificial limbs have been in use for centuries, and there has been a steady improvement in the mobility and versatility of bionic limbs. Now new advances in bionic technology and 3D printing have taken it even further. It has made it possible to artificially construct internal organs like heart , kidney , and liver . Doctors have been able to implant these into individuals that need them successfully.
10. brain signals to audible speech.
Scientists are working on creating a device that can translate brain signals to audible speech using a voice synthesizer. This would serve as an incredible tool in communicating with individuals paralyzed with the disease or traumatic injuries. Furthermore, scientists have found that they can use these devices on epileptic patients to isolate the source of their seizures.
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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.
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.
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 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 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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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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Bharat biotech has added the indian council of medical research (icmr) as co-owner of the covid-19 vaccine patent..
Bharat Biotech has added the Indian Council of Medical Research (ICMR) as co-owner of the Covid-19 vaccine patent. Notably, Bharat Biotech was working on developing the Covid-19 vaccine as a top priority to ensure product availability at the earliest. The Covid vaccine development of Bharat Biotech International Limited (BBIL) was faced with multiple challenges and all organizations were in a rush to develop vaccines and file the appropriate patents, prior to any other entity or prior to any data being published in journals.
Bharat Biotech's covid vaccine application was filed in the above circumstances and since BBIL-ICMR agreement copy, being a confidential document, was not accessible. Hence, ICMR was not included in the original application, the press release said. Though this was purely unintentional, such mistakes are not uncommon for the Patent office and therefore, Patent Law provides provisions to rectify such mistakes, the release added.
"BBIL has great respect for ICMR and is thankful to ICMR for their continuous support on various projects therefore as soon as this inadvertent mistake was noticed, BBIL has already started the process to rectify it by including ICMR as co-owner of the patent applications for Covid-19 vaccine," the press release said. It further informed that necessary legal documents are being prepared for it and BBIL will file those documents in the Patent office as soon as they are ready and signed.
Notably, these actions are in accordance with the Memorandum of Understanding (MoU) signed between ICMR-NIV Pune and BBIL for joint development of the Covid-19 vaccine in April 2020, the press release informed. (ANI)
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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By Alia Sajani June 19, 2024
P riscilla Agnew-Hines will never be able to forget that day in early 2020. On March 26, just weeks after Covid-19 officially became a global pandemic, her son died from an overdose.
Larry, 41, was a chef, a drummer for his gospel church, and the son who challenged Priscilla’s barbecue skills during summer cookouts. He also struggled with addiction. That, she knew. But what made him more prone to addiction?
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“What part of the brain triggers mental illness?” Priscilla asked during a recent interview. “If we continue to be quiet, no one will understand the process of mental illness.” So when she learned about researchers looking into the role of genetics in neurological conditions among African Americans, Priscilla was hopeful. Looking for answers, she donated her son’s brain to the study.
Priscilla was among the more than a hundred Black Baltimorians who donated the brains of their deceased loved ones for a groundbreaking initiative that’s seeking to rebuild the medical research community’s tattered relationship with Black Americans.
The study , published in the journal Nature Neuroscience last month, is the first major undertaking from the African Ancestry Neuroscience Research Initiative — a collaboration between Morgan State University, a historically Black research university in Baltimore, the Lieber Institute for Brain Development, and local community leaders. Founded in 2019, the initiative has sought to understand the biological underpinnings of some neurological conditions that are more prevalent among those with African American ancestry.
Researchers from the Lieber Institute, housed at Johns Hopkins University, found that genetics, to some degree, could explain the higher prevalence of conditions like Alzheimer’s and stroke among Black Americans, or the lower prevalence of Parkinson’s. They also speculated that environmental factors, and their impact on gene expression, might better explain higher incidence of mental health conditions like schizophrenia and depression.
The findings could someday lead to personalized therapies informed by genetic ancestry. The researchers, who worried that studies like theirs might rekindle old myths and give validity to a biological basis for race, said the focus should be on how environmental stressors and lived experiences impact gene expression. This interplay of environment and genetics could make people more, or less, prone to certain diseases.
Bianca Jones Marlin, a neuroscientist at the Zuckerman Institute at Columbia University who studies how learned information is passed down generations through genetics, lauded the researchers’ efforts to center African Americans in their study. Marlin said while the findings deepen neuroscience’s understanding of how environmental factors affect genes in the brain, she wished the researchers had zeroed in more on the impact of specific environmental factors, especially social and emotional stressors like racism, which has impacted the African American community for generations.
Still, Marlin is hopeful that the study will inspire future research to investigate how socio-emotional stressors impact gene expression, potentially predisposing Black Americans to certain diseases. By taking into account the social determinants of health , a public health concept that accounts for how biology is impacted by the environment, researchers may gain insight into the policy changes needed to improve health outcomes in the African American community.
The landmark study was made possible by the more than 100 brains (and 400 tissue samples from various brain regions) from deceased Baltimorians who self-identified as African American — an achievement in itself given the long history of racism and abuse that has marked Black Americans’ relationship with biomedical research.
In the 1800s, the pseudoscience of phrenology, the idea that bumps present on skulls could identify mental capabilities, was used to justify racism and slavery. More recently in 1951, Henrietta Lacks’ cells were collected by her physician during a cervical cancer biopsy at Johns Hopkins University. Known as HeLa cells, Lacks’ fast growing cancer cells are now used extensively in biomedical research, but were first grown in the lab by her physician without her consent. And, even decades after the infamous Tuskegee Syphilis Study , which started in 1932, a majority of Black Americans still believe that “medical researchers experiment on Black people without their knowledge or consent,” a recent Pew Research Center survey found.
Whether it is due to Black Americans’ mistrust, or because they were excluded, neuroscience research cohorts are typically dominated by participants with European descent. As a result, large genetic databases commonly used in brain research are limited in their use to investigate the disparities in neurological diseases — Black Americans are 20% more likely to experience major mental health problems , and twice as likely to develop Alzheimer’s disease .
In the Lieber Institute study, researchers first collected and sorted brain tissues based on self-reported race, hoping to understand how the lived experience of being African American in the U.S. impacted gene expression. Then, they determined genetic ancestry by analyzing the differences in specific genetic markers — African Americans can have a mix of African and European ancestry as a result of the long history of migration and slave trade.
To avoid playing into old stereotypes about biological differences between races, researchers sought help from Black neuroscientists. Scientists from Black in Neuro , a nationwide effort of Black scientists established in 2020 during the Black Lives Matter movement, worked closely with the researchers on how to communicate the findings.
The researchers found that environmental factors — that could include everything from water quality and air pollution, to racism — impacted neurological health outcomes among people of African descent. Structural changes to DNA mediated by environmental factors, called epigenetics, accounted for 15% of disease prevalence, while genetics accounts for 60% of differences between people of African and European ancestry.
They also found that genes that determine the body’s immune response, and the structure of blood vessels, were more likely to be elevated in people of African descent compared to people of European descent. The role of the immune system in affecting neurological diseases has recently gained the attention of the scientific community — since stress can affect the immune system, it may be the mechanism that makes some neurological diseases worse in Black Americans, a community that has a long history of experiencing discrimination.
The researchers found that genetics can explain only up to 26% of the likelihood of African Americans experiencing ischemic stroke, 27% for Parkinson’s disease and 30% for Alzheimer’s disease.
While the new findings advance neuroscience’s understanding of the disparities in disease prevalence among those with African-American ancestry, experts told STAT that the study itself is a model for more inclusive medical research.
“We reasoned that if we could demonstrate the success of this model in Baltimore (a city with a largely Black population and a long history of racial trauma and mistrust of medical institutions), we could institute a model that is suitable to be applied throughout neglected communities across the nation,” Alvin C. Hathaway Sr., who co-founded the African Ancestry Neuroscience Research Initiative, wrote in an editorial comment published along with the study.
Hathaway, who retired as the pastor of Union Baptist Church in Baltimore, was a crucial link in researchers’ ability to earn the trust of the African American community. During the 2020 racial reckoning after the murder of George Floyd, Hathaway said he realized going to protests wasn’t enough. Following a conversation with a member of the church, Hathaway decided that bringing more Black Americans into biomedical research was his new calling.
After the early success of the initiative’s first study, Hathaway is now focused on expanding the effort to more historically Black universities in other parts of the country.
For Priscilla, Larry’s mother, the study offered some closure, knowing that her son was part of an effort that could someday result in better medical care for those struggling with neurological and psychiatric conditions. She is now training to become a recovery coach, wanting to help others, like Larry, who are struggling with addiction.
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Read the latest news focusing on Biotech drug developments, clinical research and pharmaceuticals.
Recent research in bioelectronics and neuromorphic engineering has facilitated the development of new-generation neuroprostheses for brain repair. However, realizing their full potential requires ...
Current Research in Biotechnology. Volume 4, 2022, Pages 138-151. ... Healthcare and medical research are shifting focus to improving disease outcomes through finding hidden associations or patterns ... However, based on the current trends in biomedical research, the incorporation of big data analytics is expected to become more frequent, thus ...
We are pleased to announce that Trends in Biotechnology—the multidisciplinary journal from Cell Press—will publish original research across applied life sciences that examines bio-based solutions to real-world problems.. Trends in Biotechnology is a high-impact journal with a 40-year legacy. Our highly-cited review articles provide a foundation for an exciting new chapter for the journal.
MGI Tech Co., Ltd. ("MGI"), a company committed to building core tools and technologies that drive innovation in life science, recently set a new record for sequencing applications by ...
As the F.D.A. considers a new Alzheimer's medication, we asked experts how the rollout of a similar drug has gone. By Dana G. Smith Over the last three years, a new class of Alzheimer's drug ...
Tufts University. "Ingestible microbiome sampling pill technology advances." ScienceDaily. ScienceDaily, 12 June 2024. <www.sciencedaily.com / releases / 2024 / 06 / 240612140911.htm>. Significant ...
Current Research in Biotechnology is a peer-reviewed gold open access (OA) journal and upon acceptance all articles are permanently and freely available. It is a companion to the highly regarded review journal Current Opinion in Biotechnology (2018 CiteScore 8.450) and is part of the Current Opinion and Research (CO+RE) suite of journals. All ...
Case-control study including individual cases of calcium release deficiency syndrome (CRDS), 3 patient control groups, and genetic mouse models assesses the cardiac repolarization response on an electrocardiogram after brief tachycardia and a pause as a clinical diagnostic test for CRDS.
The "magic bullet" era. Drug therapy began centuries ago with the use of plant extracts and progressively evolved into the development of purified and targeted materials for a wide range of ...
Biotech and its applications are rapidly evolving and have the potential to revolutionize industries, including healthcare. But forward-thinking businesses, governments and academia need to work together to realize biotechnology's full promise. C4IR Serbiarecently launched at the Biotech Future Forum as biotech was revealed to be the country's ...
New biotechnology company, Ternarx, aims at changing this statistic through the development of targeted protein degrader (TPD) technology, which is designed to destroy these "undruggable" proteins ...
The Future of Biotech: Innovations and Trends in Science and Research. Biotechnology is rapidly advancing, bringing with it groundbreaking innovations and trends. As the field evolves, staying updated on the latest developments is crucial. This article explores what lies ahead for biotech, focusing on new scientific discoveries and research ...
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 ...
In this latest addition of biotechnology literature analysis, we aimed to unveil the latest trends (since 2017) in biotechnology research. By analyzing the research literature, we identified the latest popular research themes, major contributors in terms of institutions, countries/regions, and journals. 2. Materials and methods.
7. CRISPR. Clustered Regularly Interspersed Short Palindromic Repeats is a relatively new gene-editing system that has been hailed as a groundbreaking tool in medical research.Of its many uses, HIV research is one of them. Researchers can now keep up with the constant genetic mutations by actively testing newly found mutations and constantly editing them to tweak targeted therapies.
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 ...
SHARE. Bharat Biotech has added the Indian Council of Medical Research (ICMR) as co-owner of the Covid-19 vaccine patent. Notably, Bharat Biotech was working on developing the Covid-19 vaccine as a top priority to ensure product availability at the earliest. The Covid vaccine development of Bharat Biotech International Limited (BBIL) was faced ...
The researchers found that genetics can explain only up to 26% of the likelihood of African Americans experiencing ischemic stroke, 27% for Parkinson's disease and 30% for Alzheimer's disease ...