03554nam 22004575 450 991033794070332120200629134022.03-030-13754-610.1007/978-3-030-13754-0(CKB)4100000008153975(MiAaPQ)EBC5771568(DE-He213)978-3-030-13754-0(PPN)236525336(EXLCZ)99410000000815397520190508d2019 u| 0engurcnu||||||||txtrdacontentcrdamediacrrdacarrierThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals [electronic resource] /by John Geigert3rd ed. 2019.Cham :Springer International Publishing :Imprint: Springer,2019.1 online resource (338 pages)3-030-13753-8 Complexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities.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.PharmacologyPharmacyPharmacology/Toxicologyhttps://scigraph.springernature.com/ontologies/product-market-codes/B21007Drug Safety and Pharmacovigilancehttps://scigraph.springernature.com/ontologies/product-market-codes/H69010Pharmacology.Pharmacy.Pharmacology/Toxicology.Drug Safety and Pharmacovigilance.615.7Geigert Johnauthttp://id.loc.gov/vocabulary/relators/aut91349BOOK9910337940703321The Challenge of CMC Regulatory Compliance for Biopharmaceuticals2079129UNINA