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Books > Science & Mathematics > Biology, life sciences > Biochemistry > Biochemical immunology

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Lyophilized Biologics and Vaccines - Modality-Based Approaches (Hardcover, 2015 ed.) Loot Price: R4,938
Discovery Miles 49 380
Lyophilized Biologics and Vaccines - Modality-Based Approaches (Hardcover, 2015 ed.): Dushyant Varshney, Man Mohan Singh

Lyophilized Biologics and Vaccines - Modality-Based Approaches (Hardcover, 2015 ed.)

Dushyant Varshney, Man Mohan Singh

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Loot Price R4,938 Discovery Miles 49 380 | Repayment Terms: R463 pm x 12*

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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 formulations Details 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 therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides 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 launch Chapters 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.

General

Imprint: Springer-Verlag New York
Country of origin: United States
Release date: May 2015
First published: 2015
Editors: Dushyant Varshney • Man Mohan Singh
Dimensions: 235 x 155 x 24mm (L x W x T)
Format: Hardcover - Cloth over boards
Pages: 401
Edition: 2015 ed.
ISBN-13: 978-1-4939-2382-3
Categories: Books > Science & Mathematics > Biology, life sciences > Biochemistry > Biochemical immunology
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
Books > Medicine > Clinical & internal medicine > Diseases & disorders > Immunology > General
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LSN: 1-4939-2382-X
Barcode: 9781493923823

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