New expression systems and recent improvements available for current systems have the potential to revolutionize the biopharmaceutical industry. Lower costs and efficiencies of newer expression systems are driving these changes.

This book provides you with the information you need to make the shift to increased productivity. As reflected by currently marketed products, since the advent of genetic engineering in the 1970s, there has been little basic change in the technologies used for commercial-scale manufacture of biopharmaceutical products.

Nearly all current products are manufactured using much the same old, familiar technologies – primarily using Esherichia coli (E. coli bacterium), Chinese hamster ovary (CHO) cells, and the yeast saccharomyces cerevisiae (S. cerevisiae) as hosts – technologies invented in the 1970s and commercialized in the 1980s.

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By Ronald A. Rader
Published by the BioPlan Associates, Inc.
November 2008

Also available to download as a Global Digital License

 

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About the Author, Ronald A. Rader

Mr. Ronald A. Rader has a B.S. (Microbiology), an M.L.S. (Library Science), and over 25 years experience as a biotechnology and pharmaceutical information specialist, author and publisher. He is a world-class expert in biotechnology and pharmaceutical information, particularly competitive intelligence, technology and market assessments, and information resources development. Mr. Rader is the author of BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, reference concerning biopharmaceuticals. He was also author of the Antiviral Agents Bulletin, the only periodical specializing in antiviral/HIV drug and vaccine development. He also published the Federal Bio-Technology Transfer Directory, abstracting all federal, e.g., NIH, inventions and technology transfers in biotech/biomedical areas, further marketed as an online database until 2000. Recent periodical articles include:

• “(Re)defining Biopharmaceutical” Nature Biotechnology, July 2008, 26(7), p. 743-751.
• “Expression Systems for Process and Product Development: A Perspective on Opportunities for Innovator and Follow-on Product Developers,”BioProcess International, vol. 6, issue 6, suppl. 4, Success Stories in Protein Expression (lead article), p. 4-9, June 2008.
• “Biopharmaceuticals: Lack of Information Disclosure Confounds Public Trust, Particularly in the Context of Biosimilars,” BioWorld Perspectives, vol. 2, issue 18, May 1, 2008.
• “Paucity of Biopharma Approvals Raises Alarm: Lower Numbers, Novelty and Economic Impact Indicate Problems,” Genetic Engineering & Biotechnology News (GEN), March 15, 2008
• “How Big is the World Market for Biopharmaceuticals? It All Depends How You Define Biopharmaceutical,” in Friedman, Y., Best Practices in Biotechnology Business Development, Logo Press, p. 175-85, 2008.
• “What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?” Part 1: Introduction and Basic Paradigms –BioProcess International, March 2007.
• “What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?” Part 2: Information, Nomenclature, Perceptions, and the Market – BioProcess International, May 2007.
• Biopharmaceutical Approvals Review – Genetic Engineering News, Aug. 1, 2006
• What is a Biopharmaceutical, Part 1: (Bio)Technology-Based Definitions –BioExecutive, March 2005.
• What is a Biopharmaceutical, Part 2: Company and Industry Definitions –BioExecutive, May 2005.