Biotechnology is fast emerging as a field which embraces all areas of the human society. It offers tremendous research and development opportunities for creating products and processes of excellence relevant to the entire humanity. The interfusion of the new and conventional technologies has become inevitable for the socio-economic development of a nation.
The developments in biotechnology, particularly with the basic understanding of genetics, immunology, biochemistry, biochemical engineering and molecular biology have led to major breakthroughs in biotechnological products and process. The development of the field in molecular biology, plant and animal cell culture, immunology and related areas are being tuned in on with the progress of industrial development in the world. India has put considerable efforts for improving the biotechnology scenario. Perceiving the importance and promising nature of biotechnology, the Government of India had set up the National Biotechnology Board in 1982 which became a full-fledged department (known as Department of Biotechnology, DBT) in 1986 under the Ministry of Science and Technology.
Biotechnology has greatly influenced many areas of chemical industry, agriculture and medicine. One important thing is that this area of science has a very little demarcation between fundamental and applied research and also new discoveries and innovations. In most cases, it can find direct application. Cutting edge techniques and tools that have come up and revolutionized modern biotechnology include genetic engineering, cell fusion technology and structure-based molecular designs including drug development, drug targeting and drug delivery systems.
During 1980s the Government of India envisaged the need for creating a separate institutional framework to strengthen biology and biotechnology research in the country. Scientific agencies supporting research in modern biology included: Council of Scientific and Industrial Research(CSIR), Indian Council of Agricultural Research (ICAR), Indian Council of Medical Research (ICMR), Department of Science and Technology, and University Grants Commission.
In 1982 there was a breakthrough in biotechnology with the establishment of the National Biotechnology Board. Its utmost priorities were human resource development, creation of infrastructure facilities and supporting research and development (R&D) in specific areas. In February 1986 the fruition of the National Biotechnology Board prompted the Government to establish a separate Department of Biotechnology (DBT).
The Indian Government has made substantial investments in biotechnology research. Bringing Indian biotechnology products to market will require the involvement of large and small entrepreneurs and business houses. This will require substantial investments from Indian and overseas investors. The worldwide trend is that large companies are becoming major players in development of biotechnology products and also in supporting product-related biotechnology research.
Elementary research
Fundamental research is cardinal on all aspects of modern biology including development of the tools to identify, isolate, and manipulate the individual genes that govern the specific characters in plants, animals, and micro-organisms. Recombinant DNA (rDNA) technology is the basis for these new developments.
The ingenuity of the scientists and the meddlesomeness-driven research will be the keys to future accomplishments. No doubt that India had seen the seminal research work of G.N. Ramachandran, in which he elucidated the triple helix of collagen. The Ramachandran plot has proved to be basis in solving the protein structure. Fields of biosystematics using molecular approaches, mathematical modelling and genetics including genome sequencing for human beings, animals, and plants will continue to have priority as the nation moves forward. The astounding impact of genome sequencing is quite evident in many fields. Due to the discovery of numerous new genes, then short, unique, expressed sequenced tags segments are used as signatures for gene identification. The power of high throughput sequencing, together with rapidly accumulating sequenced data, is opening new routes to biosciences.
There have been major triumphs in basic bioscience in the last decade or so in India, where we have competency in practically all fields of modern biology. The institutions under the CSIR, ICMR, ICAR, DST and DBT have established a number of facilities to carry out the most advanced research work in biological sciences. In the identification of new genes, development of new drug delivery systems, diagnostics, recombinant vaccines, bioinformatics and many more related areas, considerable success has been achieved. Breakthroughs include studies on the three-dimensional structure of a novel amino acid, a long protein of mosquito (University of Pune) and demonstration of the potential of the reconstituted Sendai viral envelopes containing only the F protein of the virus, as an efficient and site-specific vehicle for the delivery of reporter genes into hepatocytes (University of Delhi).
Role of biotech companies
According to the biotechnology companies, the biotechnology is the industrial application of living organisms and biological techniques developed through original research. These companies make biotechnology products by manipulating and modifying organisms, mainly at molecular level. It is a vast discipline and has numerous practical applications in agriculture, and biopharmaceutical industry. Biotechnology products in medicine are manufactured by biotech companies using recombinant DNA technology, which encompasses genetic manipulation of cells or a monoclonal antibody. These biotech products made by biotech companies are widely used in the prevention, diagnosis or treatment of many types of diseases.
As biotechnology products are biological products, i.e. they include those where the starting material may be human or animal tissue or of microbiological origin. They often require biotech products like complex bioassay systems to monitor their potency.
There are two large groups of biological manufactured by biotech companies: Blood biotechnology products and vaccines which make up a large part of biopharmaceutical industry. Other products of the kind made by biotechnology companies include hormones, antibody products, larger peptides and a range of group of tissue derived products. At the same time assay systems are generously used by the biopharmaceutical industry to develop quality biotech products.
Biotechnology in healthcare systems
Biotechnologists are deeply involved in development of low-cost, affordable, efficient and easily accessed healthcare systems. Due to recent advances in molecular biology, immunology, reproductive medicine, genetics and genetic engineering, there is a revolution on the understanding of health and diseases, which will pave way for an era of predictive medicines. Genetic engineering has given us a means to treat various monogenetic as well as polygenetic disorders. All over the globe, there are about 40-45 biotechnology-derived therapeutics and vaccines in use and more than 550 drugs in different stages of clinical trials. The technologies have been transferred to industry. Promising leads now exist to develop vaccines for rabies, Mycobacterium tuberculosis, cholera, and other diseases. Recombinant hepatitis B vaccine and LEPROVAC are already in the market. The global market for herbal products may be around US$5 trillion by 2050.
Biotechnology in pharmaceuticals
Currently, there are more than 600 biotechnology-based diagnostics which are used in clinical practice. The polymerase chain reaction (PCR)-based diagnostics are the most common. industrial enzymes have emerged as a major vehicle for improving product quality. In India a number of groups are gearing up to produce industrial enzymes such as alpha-amylose, proteases and lipases, increasing three-fold by the end of the century, which will match or surpass the IT industry in size, importance and growth. Cell culture vaccines such as MMR and rabies, and hepatitis-B have also been introduced
Bioinformatics is now paying rich dividends, with genome projects, drug design and molecular taxonomy, all associated with information technology. Information on nucleotides and protein sequences is spreading rapidly. The number of genes characterized from a variety of organisms and the number of evolved protein structures are doubling every two years.
What the future holds?
The bioethics committee of UNESCO has framed the guidelines for ethical issues associated with the use of biotechnology in the modern era. Currently, a biosafety guideline for genetically improved organisms (GIOs) is being religiously followed to prevent harm to human health or the environment. In India, a three-level mechanism of Institutional Biosafety Committees is existing: the Review Committee on Genetic Manipulation, the Genetic Engineering Approval Committee and the state level co-ordination committees.
Biotechnology is powering ahead to create a revolution in health care. Pharma companies are moving from drug discovery and development based on medicinal chemistry to designing and developing drugs based on information provided by genomics. Antibody-based drugs, specifically monoclonal antibody-based products are making significant commercial growth. New developments in antibody products are spurred by advances in technology that have now surmounted previous technical barriers to commercialization. The development through molecular biology of new diagnostic kits and vaccines for major diseases would make the health care system more efficient and cheaper.
-The author is working with Tata Consultancy Services, Noida