The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (PDF)

Name: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Brand: Springer-Verlag GmbH
SKU: 128044377
Price: 164.99 EUR
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(Sprache: Englisch)

Autor: John Geigert

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, John Geigert

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This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for 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.

Autoren-Porträt von John Geigert

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