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000727213 020__ $$a9781493923830$$qelectronic book
000727213 020__ $$a1493923838$$qelectronic book
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000727213 035__ $$aSP(OCoLC)ocn909772448
000727213 035__ $$aSP(OCoLC)909772448
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000727213 050_4 $$aRS199.F74$$bL96 2015eb
000727213 08204 $$a615.1/9$$223
000727213 24500 $$aLyophilized biologics and vaccines$$h[electronic resource] :$$bmodality-based approaches /$$cDushyant Varshney, Manmohan Singh, editors.
000727213 264_1 $$aNew York, NY :$$bSpringer,$$c2015.
000727213 300__ $$a1 online resource (xi, 401 pages) :$$billustrations.
000727213 336__ $$atext$$btxt$$2rdacontent
000727213 337__ $$acomputer$$bc$$2rdamedia
000727213 338__ $$aonline resource$$bcr$$2rdacarrier
000727213 500__ $$aIncludes index.
000727213 5050_ $$aPreface -- Part I ? Lyophilization History and Fundamentals -- History of Lyophilization -- Heterogeneity of protein environments in frozen solutions and in the dried state -- Advance understanding of buffer behavior during lyophilization -- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles -- New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation technology -- Part II ? Lyophilized Biologics and Vaccines ? Modality Considerations -- Lyophilized Biologics -- Lyophilization of Therapeutic Proteins in Vials -- Process Scale-up and Advances in Quality by Design -- Advances in Process Analytical Technology in Freeze Drying -- Process Scale-up and Optimization of Lyophilized Vaccine Products -- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations -- Part III ? Advances in Alternate Drying -- Alternatives to Vial Lyophilization -- Spray Drying of Biopharmaceuticals -- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals -- Case Studies and Examples of Biopharmaceutical Modalities -- Processed by Bulk Crystallization or Bulk Freeze Drying -- Part IV? Regulatory, Packaging and Technology Transfer Considerations -- Lyophilization of Biologics -- An FDA Perspective -- Recent Trends in Lyophilized Delivery Devices and Packaging -- Lyophilization Technology Transfer towards Product Launch.
000727213 506__ $$aAccess limited to authorized users.
000727213 520__ $$aThis book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch lyophilized biologics or vaccine products, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fusion), complex biologics (e.g., antibody drug conjugates, PEGylated proteins) and vaccines (e.g., recombinant protein based). The authors adeptly guide you through everything you need to know, from biophysical and chemical stability considerations of proteins, to critical assessment during process scale-up, technology transfer, packaging, alternate drying and device selection for a successful process validation, regulatory submission and launch of a stable, safe and effective product. Lyophilized Biologics and Vaccines: Modality-Based Approaches 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 in frozen systems, buffer stabilization, instrumental analysis and controlled ice nucleation technology Details product development strategies based on diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Recent updates on quality-by-design and process analytical technology approaches, illustrated by case studies and FDA perspective Provides the latest account of alternate drying technologies including spray drying and bulk freeze-drying 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 and commercial manufacturing. Dushyant B. Varshney, Ph.D., has made significant contributions in manufacturing science and technology, due diligence, tech transfer, product and process development (including lyophilization), quality-by-design and process analytical technologies for biologics, vaccines and small molecules. He is currently a Director of Manufacturing Assessment, MS&T at Hospira Inc. Manmohan Singh, Ph.D., is a well-known expert in the area of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last 20 years. He is currently the Head of Global Drug Product Development at Novartis Vaccines and Diagnostics in Holly Springs, NC.
000727213 588__ $$aOnline resource; title from PDF title page (SpringerLink, viewed May 27, 2015).
000727213 650_0 $$aFreeze-drying.
000727213 650_0 $$aFrozen drugs.
000727213 7001_ $$aVarshney, Dushyant,$$eeditor.
000727213 7000_ $$aManmohan Singh,$$d1964 November 8-$$eeditor.
000727213 852__ $$bebk
000727213 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://link.springer.com/10.1007/978-1-4939-2383-0$$zOnline Access$$91397441.1
000727213 909CO $$ooai:library.usi.edu:727213$$pGLOBAL_SET
000727213 980__ $$aEBOOK
000727213 980__ $$aBIB
000727213 982__ $$aEbook
000727213 983__ $$aOnline
000727213 994__ $$a92$$bISE