Monoclonal Antibodies

1.1 Relevance of Biotechnology to Economy, Industry and Society

Developments in biotechnology have wide ranging impacts on the economy, industry and society at large. The fastest growing biotechnology market is that for diagnostics (monoclonal antibodies, biosensors, gene probes) which can be applied to humans, animals, plants the environment and industry. New diagnostic tests will lead to a revolutionary change in medical practice. The rapidity, specificity and facility of use of new diagnostic kits ushers in an era of mass diagnosis extending to the general population and reducing the damage caused by disease leading to an improvement in quality of life, with human and social benefits much larger than the direct economic benefits.

Biotechnology can accelerate the development of low cost inputs in livestock production and animal health coverage e.g. early diagnosis, prevention and prophylactic measures for overall improvement in livestock health in rural areas which are a crucial link in economic development.

The new trends will also have impacts in the pharmaceutical industry which will change from a supplier of products to a health care industry (i.,e. a supplier of a wide range of diagnostic and therapeutic products, auxiliary materials, and biomedical systems). The massive diffusion of diagnostics will move the current process of transformation towards an extended multidisciplinary base and an integration of biotechnology, microelectronics and telecommunication.

1.2 Present Status of Technologies in the World and in the India in the area of Biotechnology

Major technological changes in the world are in (i) the development of r-DNA technology based on the powers of gene cloning and splicing which allow for the production of large quantities of DNA and (ii) utilization of hybridoma technology which allows for the fusion of specific antibody producing spleen cells with myeloma cells to produce large quantities of pure antibodies. In India, the hybridoma technology is being used in several research laboratories attached to hospitals and national institutes for the production of diagnostic kits. The r-DNA technology is being developed in few of the research organizations for the expression of DNA against specific proteins. In the field of agriculture, cell fusion and tissue culture technologies are being used to target gene products into plants to obtain high yield, pest resistant hybrid seeds and plants.

1.3 Technological gaps in Biotechnology Research

The technological gaps that need to be addressed are in the area of developments of r-DNA technology, integration of disciplines like genetics, immunology, bioprocess engineering, information technology and other basic areas of science like physics, chemistry and biology.

1.4 Present Status and Projection of Markets – World wide and India in the Area of Biotechnology

The mainstay of biotech activity for the next 10 years will be human health care – diagnostic and therapeutic products. According to some global market estimates, monoclonal antibody products (mainly diagnostics, therapeutics and industrial separation agents) are expected to grow from about $1 billion sales in 1989 to about $ 8 billion by year 2000 A.D. This would comprise about 15% of the total biotechnological products available in the world market.

According to available data on projections of biotech markets in India, the market for biotech products is expected to grow to Rs. 3500 crores in India by 2000 A.D.                                                                                                                 Back