The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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Beschreibung
CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells. Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals. In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.
CMC regulatory compliance strategy for biopharmaceuticals has become vastly more complex and challenging in the past couple of years, especially as the number of gene therapies have entered development and even market approval. Biopharmaceuticals today can be either protein-based or gene-based. For gene-based biopharmaceuticals, the CMC regulatory compliance strategy must address adequate controls and patient safety concerns for viral vectors, non-viral vectors and genetically modified patient cells. Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition. This book covers effective, risk-based, and current, CMC regulatory compliance strategies for biopharmaceuticals. In this 5th edition, updates include new information on source material control in the manufacturing of biopharmaceutical drug substances, critical process controls in the manufacturing of biopharmaceutical drug substances, and more. This book is intended for biopharmaceutical professionals.
Updates real-world CMC deficiency examples with current examples Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals
Autor*in
John Geigert
Themen in »The Challenge of CMC Regulatory Compliance for Biopharmaceuticals«
biopharmaceutical monoclonal antibodies in vivo and ex vivo gene therapy engineered antibodies biosimilars Regulatory Pathways Impacting CMC Biopharmaceutical Compliance Differences in CMC Regulatory Compliance Protein-Based versus Gene-Based Biopharmaceuticals Manufacturing of Biopharmaceutical Drug Substances Materials for Manufacturing Biopharmaceutical Drug Substances