The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

• Κύριος συγγραφέας: Geigert, John (Συγγραφέας, http://id.loc.gov/vocabulary/relators/aut)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Έκδοση: 3rd ed. 2019.
• Θέματα: 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...

Πίνακας περιεχομένων:

• 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.