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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Authors: Geigert, John

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  • Updated with over 400 new or revised CMC regulatory compliance references since the 2ndedition
  • Thorough coverage of CMC regulatory compliance for recombinant proteins, monoclonal antibodies, biosimilars, genetically engineered viruses and genetically engineered cells
  • Addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process
  • Lessons learned from published FDA and EMA CMC regulatory compliance reviews of biopharmaceuticals that have sought market approval
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eBook $139.00
price for USA in USD (gross)
  • ISBN 978-3-030-13754-0
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.99
price for USA in USD
  • ISBN 978-3-030-13753-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry.  And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products.  These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products.  Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval.  The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

About the authors

John Geigert, Ph.D., RAC, is President of BioPharmaceutical Quality Solutions, which for the last 18 years has specialized in providing CMC regulatory strategy consulting for the biopharmaceutical industry. Dr. Geigert has over 40 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S. and in Europe. Dr. Geigert has served on the PDA Board of Directors, currently chairs the PDA Biopharmaceutical Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University

Table of contents (15 chapters)

Table of contents (15 chapters)

Buy this book

eBook $139.00
price for USA in USD (gross)
  • ISBN 978-3-030-13754-0
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.99
price for USA in USD
  • ISBN 978-3-030-13753-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Authors
Copyright
2019
Publisher
Springer International Publishing
Copyright Holder
Springer Nature Switzerland AG
eBook ISBN
978-3-030-13754-0
DOI
10.1007/978-3-030-13754-0
Hardcover ISBN
978-3-030-13753-3
Edition Number
3
Number of Pages
XXVIII, 426
Number of Illustrations
25 b/w illustrations, 34 illustrations in colour
Additional Information
Originally Published with the title: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biosimilars”
Topics