04817nam 2200661Ia 450 991083052260332120211007145841.01-280-94135-997866109413530-470-72379-30-470-72378-5(CKB)1000000000356125(EBL)309824(SSID)ssj0000200678(PQKBManifestationID)11183525(PQKBTitleCode)TC0000200678(PQKBWorkID)10231002(PQKB)11192421(MiAaPQ)EBC309824(OCoLC)181344646(PPN)152399275(EXLCZ)99100000000035612520060906d2007 uy 0engur|n|---|||||txtccrMedicines from animal cell culture[electronic resource] /[edited by] Glyn Stacey, John DavisChichester ;Hoboken, N.J. Wileyc20071 online resource (696 p.)Description based upon print version of record.0-470-85094-9 Includes bibliographical references and index.Medicines from Animal Cell Culture; Contents; Contributors; Preface; List of Abbreviations; 1 The Development of Animal Cell Products: History and Overview 1; FUNDAMENTAL ELEMENTS OF CELL GROWTH MEDIA 15; 2 Water Purity and Regulations; 3 Development and Optimization of Serum-free and Protein-free Media; 4 Understanding Animal Sera: Considerations for Use in the Production of Biological Therapeutics; CELL ENGINEERING FOR RECOMBINANT PRODUCTS; 5 Expression of Recombinant Biomedical Products from Continuous Mammalian Cell Lines; 6 Production of Recombinant Viral Vaccine Antigens7 A Brief Overview of the Baculovirus Expression System in Insect and Mammalian Cells8 Stability: Establishing Clones, Genetic Monitoring and Biological Performance; 9 Gene Transfer Vectors for Clinical Applications; TECHNOLOGY AND FACILITIES FOR CELL CULTURE SCALE-UP; 10 Systems for Cell Culture Scale-up; 11 Process Development and Design; 12 Facility Design for Cell Culture Biopharmaceuticals; 13 Monitoring, Control and Automation in Upstream Processing; 14 Services and Associated Equipment for Upstream Processing; 15 System and Process ValidationPROCESSING AND PRESERVATION OF CELLS AND PRODUCTS16 Cell Harvesting; 17 Protein Concentration; 18 Purifi cation Methods; 19 Virus Safety of Cell-derived Biological Products; 20 Formulation and Freeze Drying for Lyophilized Biological Medicines; 21 Cell Preservation; PROPERTIES OF CELL PRODUCTS; 22 Product Characterization from Gene to Therapeutic Product; 23 Protein Analysis; 24 Glycosylation of Medicinal Products; 25 Immunogenicity of Impurities in Cell-Derived Vaccines; 26 Potency and Safety Assessment of Vaccines and Antitoxins:Use of Cell-based Assays27 Product Stability and Accelerated Degradation StudiesCELLS AS PRODUCTS; 28 Cell Culture in Tissue Engineering; 29 The Use of Stem Cells in Cell Therapy; 30 Cells as Vaccines; RISK ASSESSMENT AND REGULATORY ASPECTS; 31 Risk Assessment of Cell Culture Procedures; 32 Standardization of Cell Culture Procedures; 33 Good Laboratory Practice for Cell Culture Processing; 34 Good Manufacturing Practice for Cell Culture Processing; 35 International Regulatory Framework; 36 New Areas: Cell Therapy and Tissue Engineering Products-Technical, Legal and Regulatory Considerations; IndexMedicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture:Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservatioAnimal cell biotechnologyPharmaceutical biotechnologyStem cellsTransplantationRecombinant proteinsTherapeutic useAnimal cell biotechnology.Pharmaceutical biotechnology.Stem cellsTransplantation.Recombinant proteinsTherapeutic use.571.638615/.19Stacey G(Glyn)1609902Davis John1952-868987MiAaPQMiAaPQMiAaPQBOOK9910830522603321Medicines from animal cell culture3937386UNINA