Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10852594 | Biologicals | 2015 | 4 Pages |
Abstract
It is important for Sponsors to understand the factors that are critical for the safety and efficacy of their product and to demonstrate to the Health Authorities that they have a control strategy that ensures safety and efficacy during all stages of development. The focus of this paper is to describe some of the challenges for the chemistry manufacturing and controls (CMC) for cell therapies being development internationally.
Keywords
FDACommon Technical Documentworking cell bankWCBcPMPPh. Eur.CLIALAFUSPCMCTSEGMPCTDCFRCATEMAGTPEuropean Medicines agencyClinical Laboratory Improvement Amendmentstransmissible spongiform encephalopathyUnited States PharmacopeiaGood Manufacturing PracticeLaminar air flowESCFood and Drug AdministrationiPS cellCell therapyEmbryonic stem cellInduced pluripotent stem cellEuropean PharmacopoeiaRegulatoryCode of Federal RegulationsCommittee for Proprietary Medicinal Products
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Biochemistry, Genetics and Molecular Biology (General)
Authors
Ian Ross Harris,