LEADER 06304nam 22006615 450 001 9910298290903321 005 20200705145207.0 010 $a1-4939-2383-8 024 7 $a10.1007/978-1-4939-2383-0 035 $a(CKB)3710000000415565 035 $a(EBL)2094244 035 $a(SSID)ssj0001500658 035 $a(PQKBManifestationID)11874347 035 $a(PQKBTitleCode)TC0001500658 035 $a(PQKBWorkID)11519116 035 $a(PQKB)10865575 035 $a(DE-He213)978-1-4939-2383-0 035 $a(MiAaPQ)EBC2094244 035 $a(PPN)186025483 035 $a(EXLCZ)993710000000415565 100 $a20150519d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aLyophilized Biologics and Vaccines $eModality-Based Approaches /$fedited by Dushyant Varshney, Manmohan Singh 205 $a1st ed. 2015. 210 1$aNew York, NY :$cSpringer New York :$cImprint: Springer,$d2015. 215 $a1 online resource (399 p.) 300 $aDescription based upon print version of record. 311 $a1-4939-2382-X 320 $aIncludes bibliographical references and index at the end of each chapters. 327 $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. 330 $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. 606 $aVaccines 606 $aAntibodies 606 $aPharmaceutical technology 606 $aVaccine$3https://scigraph.springernature.com/ontologies/product-market-codes/B16010 606 $aAntibodies$3https://scigraph.springernature.com/ontologies/product-market-codes/B14010 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 615 0$aVaccines. 615 0$aAntibodies. 615 0$aPharmaceutical technology. 615 14$aVaccine. 615 24$aAntibodies. 615 24$aPharmaceutical Sciences/Technology. 676 $a571967 676 $a610 676 $a615.19 676 $a615372 676 $a616.0798 702 $aVarshney$b Dushyant$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aSingh$b Manmohan$4edt$4http://id.loc.gov/vocabulary/relators/edt 906 $aBOOK 912 $a9910298290903321 996 $aLyophilized Biologics and Vaccines$92494363 997 $aUNINA