| 書目名稱 | Lyophilized Biologics and Vaccines | | 副標題 | Modality-Based Appro | | 編輯 | Dushyant Varshney,Manmohan Singh | | 視頻video | http://file.papertrans.cn/590/589236/589236.mp4 | | 概述 | Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics.Provides recent unders | | 圖書封面 |  | | 描述 | .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 | | 出版日期 | Book 2015 | | 關(guān)鍵詞 | Biologics; Biosimilars; Lyophilization; Modality; Vaccinology; vaccines; antibodies | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4939-2383-0 | | isbn_softcover | 978-1-4939-5568-8 | | isbn_ebook | 978-1-4939-2383-0 | | copyright | Springer Science+Business Media New York 2015 |
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