The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals
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.
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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.
List of TablesList of FiguresCh. 1Biopharmaceutical CMC Regulatory Compliance: What is It?Ch. 2Are Biopharmaceuticals Really Different?Ch. 3Developing the Corporate CMC Regulatory Compliance StrategyCh. 4Can't Ignore cGMPsCh. 5Recombinant Source Material: Master/Working BanksCh. 6Production: Expansion of the Recombinant Organism and Expression of the BiopharmaceuticalCh. 7Purification of the BiopharmaceuticalCh. 8Biopharmaceutical Drug Product ManufacturingCh. 9Physicochemical/Biological Analysis of the Biopharmaceutical ProductCh. 10Managing Process Changes - Demonstrating Product ComparabilityCh. 11Biopharmaceutical CMC OutsourcingCh. 12Concluding Thoughts on Biopharmaceutical CMC Regulatory ComplianceReferences
