BIOT 473 |
| Disposable technologies are becoming prominently used in the bioprocessing manufacturing industry by contract manufacturing organizations (CMOs) and for in-house manufacturing. This presentation will include a discussion of the regulatory issues and requirements concerning the use of disposable systems in biomanufacturing under CGMP compliance. A comparison of positive impacts (such as less intensive validation) and perceived increased burden (such as leachables/extractables issues and system integrity) will be addressed. |
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Downstream Processing: Disposable Bioprocessing
2:00 PM-4:20 PM, Thursday, August 23, 2007 BCEC -- 106, Oral
Division of Biochemical Technology |