Lyophilized Biologics and Vaccines
Modality-Based Approaches
This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates, PEGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process…
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Produktdetails
Weitere Autoren: Varshney, Dushyant (Hrsg.)
- ISBN: 978-1-4939-5568-8
- EAN: 9781493955688
- Produktnummer: 21127026
- Verlag: Springer New York
- Sprache: Englisch
- Erscheinungsjahr: 2016
- Seitenangabe: 416 S.
- Masse: H23.5 cm x B15.5 cm x D2.2 cm 628 g
- Auflage: Softcover reprint of the original 1st ed. 2015
- Abbildungen: Paperback
- Gewicht: 628
Über den Autor
Dushyant B. Varshney, Ph. D., has made significant contributions in manufacturing science and technology, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccines and small molecules. Having earned his Ph.D. from the University of Iowa, Dr. Varshney has authored several peer-reviewed scientific publications, review articles, and book chapters, and has presented at several international conferences and chaired scientific workshops. He is currently a Director of Manufacturing Assessment, MS&T at Hospira, Inc. He has previously worked at Novartis, Bristol-Myers Squibb, Sanofi and Eli Lilly & Company. Manmohan Singh, Ph.D., is a well-known expert in the area of vaccine formulations and adjuvant research, and has been working in vaccine R&D for the last 20 years. He has authored over 130 peer reviewed manuscripts, review articles, and book chapters, and has edited five books in this area. Dr. Singh is on the editorial board of 11 International Journals and has collaborated in organizing several international vaccine conferences. Currently, he is the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC 27540.
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