9781493923823 - lyophilized biologics and vaccines: modality-based approaches (5 Ergebnisse)
- Hardcover
Anbieter: Universitätsbuchhandlung Herta Hold GmbH, Berlin, DeutschlandUniversitätsbuchhandlung Herta Hold GmbH
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EUR 15,00
EUR 30,00 VersandVersand von Deutschland nach USAAnzahl: 2 verfügbar
24 cm. XI, 401 p. Hardcover. Versand aus Deutschland / We dispatch from Germany via Air Mail. Einband bestoßen, daher Mängelexemplar gestempelt, sonst sehr guter Zustand. Imperfect copy due to slightly bumped cover, apart from this in very good condition. Stamped. Sprache: Englisch.
- Hardcover
Anbieter: SpringBooks, Berlin, DeutschlandSpringBooks
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EUR 36,48
EUR 39,90 VersandVersand von Deutschland nach USAAnzahl: 1 verfügbar
Hardcover. Zustand: As New. Like new. Will be dispatched immediately from Germany.
- Hardcover
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes KönigreichRia Christie Collections
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EUR 177,92
EUR 13,98 VersandVersand von Vereinigtes Königreich nach USAAnzahl: Mehr als 20 verfügbar
Zustand: New. In.
- Hardcover
Anbieter: AHA-BUCH GmbH, Einbeck, DeutschlandAHA-BUCH GmbH
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EUR 179,61
EUR 63,94 VersandVersand von Deutschland nach USAAnzahl: 1 verfügbar
Buch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), comp…lex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products.Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulationsDetails the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeuticsDetails an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspectiveProvides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studiesProvides a step-by-step guide through critical considerations during process scale-up, technology transfer,packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launchChapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.
- Hardcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 249,44
EUR 14,58 VersandVersand von Vereinigtes Königreich nach USAAnzahl: 2 verfügbar
Hardcover. Zustand: Brand New. 1st edition. 401 pages. 9.25x6.25x1.00 inches. In Stock.
