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

    Good Automation Manufacturing Practice (GAMP)


    Scale-up of Saccharomyces cerevisiae fermentation for the manufacture of recombinant human albumin A robust fermentation process for the large scale Validation is critical to the reliability of large scale biopharmaceutical production and Good Automation Manufacturing Practice (GAMP) provides a comprehensive guide to the validation of automated systems. Just as extensive analysis cannot alone provide a high quality biopharmaceutical protein product, exhaustive testing can not completely validate a biopharmaceutical computer system. GAMP provides a mechanism for structuring quality into computer system development from the beginning of its design through to its testing and deployment for cGMP production. This chapter describes automation applications and current challenges, the scope and advantages of the GAMP approach, and opportunities for further efficiencies in computer system development and validation. Experiences and “lessons learned” from several executed retrospective and prospective computer system validation projects are incorporated throughout this chapter.

    About the Authors

    Beth Junker, Ph.D.
    Senior Director, Fermentation Development and Operations, Merck Research Laboratories

    Beth Junker received her BSE degree in chemical engineering (Princeton University, 1984) and her Ph.D. degree in biochemical engineering (Massachusetts Institute of Technology, 1989). For the past 15 years, she has been working in the fermentation development and operations area of the Bioprocess Research and Development Department of Merck Research Laboratories. Along with process development responsibilities for natural product-producing fermentations, Dr. Junker is responsible for developing scale-up techniques for suspension animal cell processes. She has led efforts to culture hybridoma and insect cells in modified-microbial and dual use fermenters, as well as demonstrate viral production for anchorage-dependent cells using both microcarriers and static mixer reactors.

    Contributing Authors Jens Christensen, Paul Kardos, W. Smizaski, T. Brix Merck Research Laboratories, Rahway, NJ

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