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

    Microbiological Methods in Support of Manufacturing

    This chapter provides an overview of the various microbiological testing performed in pharmaceutical and biotechnology manufacturing. Traditional test methods and the associated automated or alternative microbiological test methods are provided.

    About the Authors

    Scott Sutton
    Vectech Pharmaceutical Consultants, Inc.

    Dr. Sutton earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he went to work for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at Alcon Laboratories (Fort Worth, TX). Dr. Sutton left Alcon Laboratories in 2004 as a Director in the R&D division to accept a position as Pharma Consultant (Microbiology) with Vectech Pharmaceutical Consultants, Inc. There he has assisted companies as varied as start-ups, generics, and established pharmaceutical innovators with laboratory management and compliance issues, process change opportunities, project management, and implementation of rapid microbiological methodologies. He is now Senior Director, Microbiology Services for Vectech. Dr. Sutton is an active author and speaker for the industry. In addition, he is active in a volunteer capacity, being involved with the USP Analytical Microbiology Committee of Experts since 1993. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum. org) and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet Ė The Microbiology Network ( that provides services to microbiology related userís groups. This service also supports two Email lists, the first devoted to pharmaceutical microbiology ( and the second devoted to pharmaceutical stability (

    Jeanne Moldenhauer
    Vice President
    Excellent Pharma Consulting
    Jeanne Moldenhauer is the Vice President of Excellent Pharma Consulting. She has thirty years experience in the pharmaceutical, biotech, and device industry. She is the founder of the Rapid Microbiology Userís Group(r). She is a senior quality and regulatory consultant. Additionally, she is a certified quality engineer and a certified quality manager with the American Society of Quality.

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