BIOT 59 |
| Genentech and its partners have demonstrated post-approval comparability for numerous manufacturing site transfers, process changes, and new formulations. Guidelines have been developed for determining quantitative and qualitative acceptance criteria. A decision tree for physicochemical, biological, non-clinical, and/or clinical assessments has also been developed. Comparability case studies will be presented, including examples where physicochemical analyses were supplemented with in-vivo studies. |
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Commercialization of Biologics: Case Studies: Post-Approval Changes & Comparability Challenges
2:00 PM-4:20 PM, Sunday, August 19, 2007 BCEC -- 109B, Oral
Division of Biochemical Technology |