The challenge of CMC regulatory compliance for biopharmaceuticals and other biologics

著者

書誌事項

The challenge of CMC regulatory compliance for biopharmaceuticals and other biologics

John Geigert

Springer, c2013

2nd ed

  • : [hardcover]

大学図書館所蔵 件 / 全1件

この図書・雑誌をさがす

注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.)

目次

Complexity of Biologica CMC Regulation.- Biologics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Source Materials for Biologics.- Manufacture of the Biologic API.- The Biologic Final Product Process.- Complex Process-Related Impurities.- Molecular Structural Analysis.- Functional Activity (Potency).- Setting Specifications and Expiry Dates.- Demonstrating Product Comparability.- CMC-Focused Regulatory Meetings.- References.

「Nielsen BookData」 より

詳細情報

ページトップへ