The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

• Main Author: Geigert, John (Author, http://id.loc.gov/vocabulary/relators/aut)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Edition: 3rd ed. 2019.
• Subjects: Pharmacology.; Pharmacy.; Pharmacology/Toxicology.; Drug Safety and Pharmacovigilance.

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 engine...