LEADER 04251nam 22006615 450 001 9910298288403321 005 20200702023940.0 010 $a3-662-45024-0 024 7 $a10.1007/978-3-662-45024-6 035 $a(CKB)3710000000305965 035 $a(EBL)1966090 035 $a(SSID)ssj0001385879 035 $a(PQKBManifestationID)11767065 035 $a(PQKBTitleCode)TC0001385879 035 $a(PQKBWorkID)11341304 035 $a(PQKB)10844756 035 $a(DE-He213)978-3-662-45024-6 035 $a(MiAaPQ)EBC1966090 035 $a(PPN)183089715 035 $a(EXLCZ)993710000000305965 100 $a20141127d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aVaccine Analysis: Strategies, Principles, and Control$b[electronic resource] /$fedited by Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin 205 $a1st ed. 2015. 210 1$aBerlin, Heidelberg :$cSpringer Berlin Heidelberg :$cImprint: Springer,$d2015. 215 $a1 online resource (669 p.) 300 $aDescription based upon print version of record. 311 $a3-662-45023-2 320 $aIncludes bibliographical references and index. 327 $aLive Attenuated Viral Vaccines -- Inactivated Viral Vaccines -- Recombinant Virus Like Particle Protein Vaccines -- Analysis of influenza vaccines -- Live-attenuated and inactivated whole-cell bacterial vaccines -- Analytical control strategy of bacterial subunit vaccines -- Bacterial Polysaccharide Vaccines: Analytical Perspectives -- Glycoconjugate vaccines -- Vaccines in research and development: new production platforms and new biomolecular entities for new needs -- Role of Analytics In Viral Safety -- Deep Sequencing Applications for Vaccine Development and Safety -- Quality-by-design: As related to analytical concepts, control and qualification -- Vaccine Potency Assays -- Establishing a Shelf-life and Setting Lot-release Specifications -- Vaccine Reference Standards -- Lot Release of Vaccines by Regulatory Authorities and Harmonization of Testing Requirements -- Dendritic cell targeting vaccines. 330 $aThis book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure. 606 $aVaccines 606 $aImmunology 606 $aMedical biochemistry 606 $aVaccine$3https://scigraph.springernature.com/ontologies/product-market-codes/B16010 606 $aImmunology$3https://scigraph.springernature.com/ontologies/product-market-codes/B14000 606 $aMedical Biochemistry$3https://scigraph.springernature.com/ontologies/product-market-codes/H35005 615 0$aVaccines. 615 0$aImmunology. 615 0$aMedical biochemistry. 615 14$aVaccine. 615 24$aImmunology. 615 24$aMedical Biochemistry. 676 $a610 676 $a612015 676 $a615372 676 $a616079 702 $aNunnally$b Brian K$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aTurula$b Vincent E$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aSitrin$b Robert D$4edt$4http://id.loc.gov/vocabulary/relators/edt 906 $aBOOK 912 $a9910298288403321 996 $aVaccine Analysis: Strategies, Principles, and Control$92500507 997 $aUNINA