BIOT 56 |
| Although EnbrelŪ (etanercept) was approved nearly nine years ago, interest in its history remains strong because of the series of post-approval changes that have been filed with regulatory agencies. To meet the growing market demand since licensure, applications have included modifications to increase yield and improve robustness, as well as to add manufacturing sites (five to date). Key considerations throughout this life time have been to show process consistency with scale-up and transfer and to demonstrate product comparability. This talk will cover some of the process modifications and their rationales, as well as the strategy for rapid filing and approval at multiple manufacturing sites. |
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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 |