Biotechnology Products and Development

Biotechnology products are those that are prepared using biological organisms, rather than the usual types of industrial chemical synthesis. Biological organisms may be used in vivo, ex vivo or in vitro to make these products. 

Biotechnology products are diverse, including polypeptides, biological organisms themselves (living, dead or attenuated), genes, any type of 

Biological products have a longer history than is generally assumed. At one time small pox accounted for 10% of deaths in some countries. The development of cow pox vaccination in 1796, and later the Variocella vaccine, has led to small pox being the only infectious disease ever to have been eradicated from the planet the final outbreak was after a laboratory accident in 1979, leading to a small number of cases. 

It is beyond the scope of this chapter to discuss all potential applications and all present technologies associated with biological drugs. We wish to concentrate here on the newer technologies that are actually used on either an investigational or approved basis in human beings, and can only provide an overview. Thus, vaccines, fermented antibiotics, blood products, diagnostic products (e.g. antibody-based assay systems) and devices 

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier 2007 John Wiley Sons, Ltd ISBN 978-0-470-09313-9 

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Plant cell culture methods constitute a most exciting part of food biotechnology research and development with many areas for food improvement, involving plant production, plant resistance and functionality, nutritional quality of plant foods and production of natural food ingredients (A9-51). 

Pharmacokinetic and Pharmacodynamic Considerations in the Development of Biotechnology Products and Large Molecules... 

As a result of this research, the availability of biotechnology products to develop is no longer an issue. At the present time, over 350 peptide and protein drugs are in various stages of clinical development. Many other candidates will likely be identified as genomic studies successfully translate genetic data into knowledge about proteins and their functions. 

This work was partially supported by Biotechnology Research and Development Corporation grant no. 32-1-096 and the USDA, Agricultural Research service. Mention of a trademark, proprietary product, or vendor does not constitute a guarantee or warranty of the product by the U.S. Department of Agriculture and does not imply its approval to the exclusion of other products or vendors that may also be suitable. 

Dale E Johnson BSc PharmD PhD DABT is Vice President, Preclinical Development for Chiron Corporation, Emeryville, California, where he heads the worldwide non-clinical development effort for biotechnology products and small... 

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