LEADER 02565nam 2200469Ia 450 001 9910708105503321 005 20200520144314.0 010 $a0-387-76643-X 010 $a1-282-83076-7 010 $a1-4614-2491-7 010 $a9786612830761 035 $a(CKB)2550000000015861 035 $a(VLeBooks)9780387766430 035 $a(MiAaPQ)EBC511523 035 $a(EXLCZ)992550000000015861 100 $a20091002d2010 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aCurrent trends in monoclonal antibody development and manufacturing /$fedited by Steven J. Shire ... [et. al.] 205 $a2010 210 $aNew York $cSpringer$d2010 215 $a1 online resource (341 p.) 225 $aBiotechnology: pharmaceutical aspects 311 $a0-387-56826-3 311 $a0-387-76642-1 330 $a Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission. 606 $aMonoclonal antibodies 606 $aImmunology 615 0$aMonoclonal antibodies. 615 0$aImmunology. 676 $a615.37 701 $aShire$b Steven J$01745962 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910708105503321 996 $aCurrent trends in monoclonal antibody development and manufacturing$94177337 997 $aUNINA