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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

  • Book
  • © 2013

Overview

Authors:
  1. John Geigert

    1. BioPharmaceutical Quality Solutions, Carlsbad, USA

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  • Highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment

  • Presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing

  • Revised 2nd Edition is broadened to include biopharmaceuticals (biotech drugs) and other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

  • Includes supplementary material: sn.pub/extras

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Table of contents (13 chapters)

  1. Front Matter

    Pages i-xxix
    Download chapter PDF

  2. Complexity of Biologic CMC Regulation

    • John Geigert
    Pages 1-20

  3. Biologics Are Not Chemical Drugs

    • John Geigert
    Pages 21-33

  4. An Effective CMC Strategy is Possible

    • John Geigert
    Pages 35-58

  5. Challenge of Adventitious Agent Control

    • John Geigert
    Pages 59-104

  6. Source Materials for Biologics

    • John Geigert
    Pages 105-137

  7. Manufacture of the Biologic API

    • John Geigert
    Pages 139-178

  8. The Biologic Final Product Process

    • John Geigert
    Pages 179-198

  9. Complex Process-Related Impurities

    • John Geigert
    Pages 199-219

  10. Molecular Structural Analysis

    • John Geigert
    Pages 221-237

  11. Functional Activity (Potency)

    • John Geigert
    Pages 239-256

  12. Setting Specifications and Expiry Dates

    • John Geigert
    Pages 257-290

  13. Demonstrating Product Comparability

    • John Geigert
    Pages 291-319

  14. CMC-Focused Regulatory Meetings

    • John Geigert
    Pages 321-329

  15. Back Matter

    Pages 331-338
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Keywords

About this book

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Authors and Affiliations

  • BioPharmaceutical Quality Solutions, Carlsbad, USA

    John Geigert

About the author

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

Bibliographic Information

  • Book Title: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

  • Authors: John Geigert

  • DOI: https://doi.org/10.1007/978-1-4614-6916-2

  • Publisher: Springer New York, NY

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Springer Science+Business Media New York 2013

  • Hardcover ISBN: 978-1-4614-6915-5Published: 07 May 2013

  • Softcover ISBN: 978-1-4939-4399-9Published: 23 August 2016

  • eBook ISBN: 978-1-4614-6916-2Published: 08 July 2014

  • Edition Number: 2

  • Number of Pages: XXIX, 338

  • Number of Illustrations: 7 b/w illustrations, 17 illustrations in colour

  • Topics: Pharmaceutical Sciences/Technology, Biomedicine general

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