LEADER 04446nam 2200589 450 001 9910452528403321 005 20200520144314.0 010 $a1-118-69503-8 035 $a(CKB)2550000001117278 035 $a(EBL)1368915 035 $a(OCoLC)858654001 035 $a(SSID)ssj0000981822 035 $a(PQKBManifestationID)11590917 035 $a(PQKBTitleCode)TC0000981822 035 $a(PQKBWorkID)10982461 035 $a(PQKB)11137247 035 $a(MiAaPQ)EBC1368915 035 $a(DLC) 2013016910 035 $a(Au-PeEL)EBL1368915 035 $a(CaPaEBR)ebr10763013 035 $a(CaONFJC)MIL517716 035 $a(EXLCZ)992550000001117278 100 $a20130424d2013 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aBiological drug products $edevelopment and strategies /$fedited by Wei Wang, Manmohan Singh 210 1$aHoboken, New Jersey :$cWiley,$d2013. 215 $a1 online resource (746 p.) 300 $aDescription based upon print version of record. 311 $a1-118-14889-4 311 $a1-299-86465-1 320 $aIncludes bibliographical references and index. 327 $aAn overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish -- Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke -- Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza -- Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver -- Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil -- Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco -- Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah -- Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens -- Chemical and genetic modification / M Farys ... [et al.] -- Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken -- Protein/peptide formulation development / Satoshi Ohtake and Wei Wang -- Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah -- Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij -- Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta -- Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte -- The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest -- Nucleic acid vaccines / Rachel Buglione-Corbett ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala -- Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal -- Controlled-release systems for biologics / Mayura Oak ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong. 330 $a Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for th 606 $aDrug development 606 $aDrugs$xResearch 608 $aElectronic books. 615 0$aDrug development. 615 0$aDrugs$xResearch. 676 $a615.1/9 701 $aWang$b Wei$f1957 March 10-$0914100 701 $aManmohan Singh$f1964 November 8-$0914101 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910452528403321 996 $aBiological drug products$92048039 997 $aUNINA