The Challenge of CMC Regulatory Compliance for Biopharmaceuticals :

By (author)Geigert

This book provides an in-depth exploration of the complexities surrounding supply chain globalization, de-globalization, and the prospective re-globalization.

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Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition.

SKU: 9783031319082
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Weight 1 kg
Book Author

Geigert

Edition

1st

Format

Hardback

ISBN

9783031319082

Language

English

Pages

612

Publication Year

Publisher

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