| BIOT | Sunday, August 19, 2007 | ||
2:00 PM-4:20 PM BCEC -- 109B, Oral | |||
Commercialization of Biologics: Case Studies: Post-Approval Changes & Comparability Challenges | |||
| Presiding: | Steven Lee Vikram Paradkar | ||
| 2:00 PM | Introductory Remarks | ||
| 2:05 PM | 56 | Post approval changes for a commercial process: An historical look Carole Heath, Hassan Madani | |
| 2:25 PM | 57 | Case study: Downstream purification support of a cell culture raw material change for a licensed mAb product Frank Maslanka | |
| 2:45 PM | 58 | Rituximab post approval changes and comparability assessments Robert Kiss, Srikanth R. Chary, Steven Meier, Jason C. Goodrick, Dana C. Andersen | |
| 3:05 PM | Intermission | ||
| 3:15 PM | 59 | Demonstrating comparability for post approval CMC changes Reed Harris | |
| 3:35 PM | 60 | Comparability protocol to support a chromatography resin change Peter J. Kramer, Rob Frankenberg, Ramadas Bhat, Parris Burd, Andrew Hetherington | |
| 3:55 PM | 61 | Investigation of an ultrafiltration yield problem for a conjugate vaccine Shwu-Maan Lee, Bob Kruse, Amy Robinson, John Davis, Chris Donaldson | |
| 4:15 PM | Concluding Remarks | ||
Symposium Grid -- Division of Biochemical Technology -- Session Listing
The 234th ACS National Meeting, Boston, MA, August 19-23, 2007