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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Produktform: E-Buch Text Elektronisches Buch in proprietärem

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.  weiterlesen

Elektronisches Format: PDF

Sprache(n): Englisch

ISBN: 978-3-031-31909-9 / 978-3031319099 / 9783031319099

Verlag: Springer International Publishing

Erscheinungsdatum: 15.06.2023

Seiten: 573

Auflage: 4

Autor(en): John Geigert

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