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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Large-Scale Microbial Production Technology for Human Therapeutic Products

    Recombinant microbial production systems have delivered major medicines such as G-CSF, insulins, interferons, recombinant Hepatitis B vaccine, and human growth hormones. Recombinant E. coli and yeast systems are two dominant microbial host systems. This chapter introduces therapeutic products manufactured by microbial processes, briefly summarizes expression systems of recombinant E. coli and yeasts, and discusses physiological factors and their relationships that are important for the design of E. coli and yeast-based processes. Typical unit operations of fermentation and purification of recombinant therapeutic proteins are described here. This chapter also describes some principles, rationales and applications of scale-up technologies, and stresses manufacturability issues for large-scale production. A brief discussion of product quality and recent regulatory considerations for recombinant microbial therapeutic proteins are included. Finally, this chapter concludes with a forward-looking perspective of microbial production technology.

    About the Author

    Xiaoming Yang, Ph.D.
    Scientific Director, Amgen Inc.

    Dr. Xiaoming (Jerry) Yang is currently a Scientific Director in Process & Analytical Sciences at Amgen, Inc., Thousand Oaks, California. He is one of the leading scientists for Amgen’s mammalian and microbial platform technologies. Dr. Yang has eighteen years of experience in bioprocess development and biologics GMP manufacturing technology. He has managed both upstream and downstream process development projects from early clinical development CMC filing to commercial registration, and he has developed processes covering a wide range of host systems including E. coli, yeast, CHO and other organisms. He earned his Ph.D. in Biochemical Engineering from Rutgers University, New Jersey, USA. He is a board member of the Editorial Advisory and Peer-Review Board for BioProcess International. He is the Chair of the Special Conference Committee for the Society of Industrial Microbiology (SIM) and a member of AIChE. He is the conference chair of “Recent Advances in Fermentation Technology” 2005-2007. He is also chairing sessions for ACS 2007 and Biochemical Engineering Conference XV (2007).


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