The Challenge of CMC Regulatory Compliance for Biopharmaceuticals - Hardcover
- PublisherSpringer
- Publication date2023
- ISBN 10 3031319087
- ISBN 13 9783031319082
- BindingHardcover
- LanguageEnglish
- Edition number4
- Number of pages608
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Published by
Springer, Berlin|Springer Nature Switzerland|Springer, 2023
ISBN 10: 3031319087
ISBN 13: 9783031319082
New
Hardcover
Seller: moluna, Greven, Germany
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Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. 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. Seller Inventory # 842326685
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Published by
Springer Nature Switzerland, Springer Nature Switzerland Jun 2023, 2023
ISBN 10: 3031319087
ISBN 13: 9783031319082
New
Hardcover
Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, Germany
Seller rating 5 out of 5 stars
Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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.Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but incan readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals. 612 pp. Englisch. Seller Inventory # 9783031319082
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