BookJohn Geigert.
Summary: 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.
Contents:
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.