The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

20.05.2019

Englisch

9783030137533

Springer International Publishing

Nein

John Geigert

426

3rd edition 2019

Gebundene Ausgabe

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

pharmaceutical QA/QC, F-I-H studies, risk based clinical development, biotech drugs, biosimilars, recombinant protein, monoclonal antibodies, CGT-cell and gene therpy products, living genetically engineered viruses, ATMPs-Advanced Therapy Medicinal Products, RMAT-Regenerative Medicines Advanced Therapy, PRIME-Priority medicines, risk based clinical development

MKG - Pharmakologie

235 mm

15.5 cm