ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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An industry that creates, develops, and markets a variety of techniques that use living organisms, or substances from those organisms, to make or modify a product by microbial and biochemical processes. A common misconception is that biotechnology refers only to recombinant DNA or gene splicing work. Recombinant DNA is only one of the many techniques used to derive products for organisms, plants, and parts of both for the biotechnology industry. A list of areas covered by the term biotechnology would more properly include: plant tissue culture, cell fusion techniques (especially for the production of monoclonal antibodies), enzyme systems, plant breeding, meristem culture, fermentation, and others.

See also: Green Biotechnology Red Biotechnology White Biotechnology


A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody), hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical, medical diagnostic device, food, animal and plant industries.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007


1. The use of biological processes or organisms for the production of materials and services of benefit to humankind. Biotechnology includes the use of techniques for the improvement of the characteristics of economically important plants and animals and for the development of micro-organisms to act on the environment.

2. The scientific manipulation of living organisms, especially at the molecular genetic level, to produce new products, such as hormones, vaccines or monoclonal antibodies.

Publication Source: Food and Agricultural Organization of the United Nations (FAO)
Publication Date: 1999

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