9781493955688 - lyophilized biologics and vaccines: modality-based approaches (11 risultati)

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Da: Ria Christie Collections, Uxbridge, Regno UnitoRia Christie Collections
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Condizione: New. In.

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Da: Books Puddle, New York, NY, U.S.A.Books Puddle
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Condizione: New. pp. 412 Softcover reprint of the original 1st ed. 2015 edition NO-PA16APR2015-KAP.

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Da: preigu, Osnabrück, Germaniapreigu
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Taschenbuch. Condizione: Neu. Lyophilized Biologics and Vaccines | Modality-Based Approaches | Dushyant Varshney (u. a.) | Taschenbuch | xi | Englisch | 2016 | Springer | EAN 9781493955688 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | An…bieter: preigu.

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Da: Revaluation Books, Exeter, Regno UnitoRevaluation Books
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EUR 180,91
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Paperback. Condizione: Brand New. reprint edition. 412 pages. 9.25x6.10x0.98 inches. In Stock.

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Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH
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EUR 130,67
EUR 63,14 spedizioneSpedito da Germania a U.S.A.Quantità: 1 disponibili
Taschenbuch. Condizione: 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, fu…sed), complex 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.

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- Print on Demand
Da: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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EUR 98,25
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Condizione: new. Questo è un articolo print on demand.

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- Print on Demand
Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermaniaBuchWeltWeit Ludwig Meier e.K.
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EUR 123,04
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Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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), complex 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. 416 pp. Englisch.

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- Print on Demand
Da: moluna, Greven, Germaniamoluna
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EUR 105,45
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Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeuticsProvides recent understanding of hetero…geneity of protein environme.

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- Print on Demand
Da: Majestic Books, Hounslow, Regno UnitoMajestic Books
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EUR 154,97
EUR 7,60 spedizioneSpedito da Regno Unito a U.S.A.Quantità: 4 disponibili
Condizione: New. Print on Demand pp. 412.

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- Print on Demand
Da: Biblios, frankfurt am main, HESSE, GermaniaBiblios
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EUR 158,69
EUR 9,95 spedizioneSpedito da Germania a U.S.A.Quantità: 4 disponibili
Condizione: New. PRINT ON DEMAND pp. 412.

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- Print on Demand
Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germaniabuchversandmimpf2000
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 123,04
EUR 60,00 spedizioneSpedito da Germania a U.S.A.Quantità: 1 disponibili
Taschenbuch. Condizione: Neu. This item is printed on demand - Print on Demand Titel. Neuware -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., mo…noclonal, fused), complex 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 technologyExplains 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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 416 pp. Englisch.