{"product_id":"9781493923823","title":"Lyophilized Biologics and Vaccines: Modality-Based Approaches","description":"\u003ch1\u003eLyophilized Biologics and Vaccines: Modality-Based Approaches\u003c\/h1\u003e \u003ch2\u003eVarshney, Dushyant; Singh, Manmohan\u003c\/h2\u003e \u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis 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., \u003ci\u003emonoclonal, fused\u003c\/i\u003e), complex biologics (e.g., \u003ci\u003eantibody drug conjugate, PEGylated proteins\u003c\/i\u003e), and vaccines (e.g., \u003ci\u003erecombinant-protein based\u003c\/i\u003e). 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.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003eLyophilized Biologics and Vaccines: Modality-Based Approaches\u003c\/i\u003e 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: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eProvides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations\u003c\/li\u003e\n\u003cli\u003eDetails the latest developments in instrumental analysis and controlled ice nucleation technology \u003c\/li\u003e\n\u003cli\u003eExplains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics\u003c\/li\u003e\n\u003cli\u003eDetails an exhaustive update on quality-by-design and process analytical technology  approaches, illustrated superbly by case studies and FDA perspective\u003c\/li\u003e\n\u003cli\u003eProvides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies\u003c\/li\u003e\n\u003cli\u003eProvides 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\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eChapters 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.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e \u003ch3\u003eDetails\u003c\/h3\u003e \u003cp\u003ePublished by: Springer\u003c\/p\u003e \u003cp\u003ePublication Date: 2015-05-21\u003c\/p\u003e \u003cp\u003eFormat: Hardcover\u003c\/p\u003e \u003cp\u003eISBN-13: 9781493923823\u003c\/p\u003e \u003cp\u003eDOI: 10.1007\/978-1-4939-2383-0\u003c\/p\u003e \u003cp\u003eDimensions: 235cm x155cm\u003c\/p\u003e \u003cp\u003ePages: 401\u003c\/p\u003e ","brand":"Springer New York","offers":[{"title":"Default Title","offer_id":44395464327308,"sku":"9781493923823","price":161.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9781493923823.jpg?v=1775842001","url":"https:\/\/fh90cf-fv.myshopify.com\/products\/9781493923823","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}