The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)Due to the inherent complexity of these products, there is no single stability- indicating assay or parameter that profiles the stability characteristics. ... The manufacturer is referred to the ICH Harmonised Tripartite Guideline: a#39;Stability Testing of Biotechnological/ Biological Productsa#39;. ... to the analytical methods employed in testing those batches, to the stability of the biologic batches, and to the clinicalanbsp;...

Title:The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author:John Geigert
Publisher:Springer Science & Business Media - 2014-07-08


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