The Challenge of CMC Regulatory Compliance for pdf

The Challenge of CMC Regulatory Compliance for

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Description of the Book:

Author: John Geigert
Published by Springer US
ISBN: 978-1-4613-4804-7
DOI: 10.1007/978-1-4419-9131-7

Table of Contents:

Biopharmaceutical CMC Regulatory Compliance: What is It?nAre Biopharmaceuticals Really Different?nDeveloping the Corporate CMC Regulatory Compliance StrategynCan’t Ignore cGMPsnRecombinant Source Material: Master/Working BanksnProduction: Expansion of the Recombinant Organism and Expression of the BiopharmaceuticalnPurification of the BiopharmaceuticalnBiopharmaceutical Drug Product ManufacturingnPhysicochemical/Biological Analysis of the Biopharmaceutical ProductnManaging Process Changes — Demonstrating Product ComparabilitynBiopharmaceutical CMC OutsourcingnConcluding Thoughts on Biopharmaceutical CMC Regulatory Compliance’, “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

• Creator/s: Geigert, John
• Date: 2004
• Book Topics/Themes: Pharmaceutical biotechnology industry, Pharmaceutical biotechnology, Pharmaceutical biotechnology industry, Pharmaceutical biotechnology

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