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008			150519s2015 xxu| s |||| 0|eng d
020			_a9781493923830
024	7		_a10.1007/978-1-4939-2383-0 _2doi
040			_dES-MaUEC
050		4	_aRS199.F74 _bL967 2015
245	1	0	_aLyophilized Biologics and Vaccines : _bModality-Based Approaches _cedited by Dushyant Varshney, Manmohan Singh.
260			_aNew York _bSpringer International Publishing _c2015
300			_a1 recurso en línea (XI, 401 p.) _b99 ilustraciones, 68 ilustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_aPreface -- Part I â€{u0339}ophilization 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 â€{u0339}ophilized Biologics and Vaccines â€{u036F}dality 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 â€{u0064}vances 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 IVâ€{u04A5}gulatory, 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.
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,ÂЅGylated 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 theÂ{uC874}est 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. Âĵshyant 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, vaccinesÂ{u1BA4} small molecules. He is currently a Director of Manufacturing Assessment, MS&T at Hospira Inc. Â{u0361}nmohan 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.
650		7	_2embne _9161127 _aTecnología farmacéutica
700	1		_aVarshney, Dushyant _eeditor literario _993480 _0Local
700	1		_aSingh, Manmohan _eeditor literario _984623 _0Local
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-1-4939-2383-0 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
907			_a.b12897814 _b10-10-17 _c18-01-16
942			_2lcc _cLE
945			_aRS199.F74 L967 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11567430 _z06-04-17
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