| BIOT | Tuesday, August 21, 2007 | ||
3:00 PM-5:20 PM BCEC -- 108, Oral | |||
Commercialization of Biologics: Impact of Design Space Philosophy & Emerging Regulations on Process Validation | |||
| Organizers: | Greg Knipp Keith Webber Anjali Kataria | ||
| 3:00 PM | 166 | Quality by design and process analytical technology for freeze drying Michael Pikal | |
| 3:20 PM | 164 | A systematic method for design space definition Roy D. Hegedus | |
| 3:40 PM | 165 | Apply design space philosophy in the establishment of process validation parameters and acceptance criteria Xiangyang Wang, Jean Harms, Pim Van Hoek, Anurag S. Rathore | |
| 4:00 PM | Intermission | ||
| 4:20 PM | 163 | Efficient approach to setting validation acceptance criteria for a biopharmaceutical process Tom Gleason, Rick Burdick, Steve Rausch, James E Seely | |
| 4:40 PM | 167 | Critical process parameters and design space Peter W. Wojciechowski | |
| 5:00 PM | 168 | Use of online Process Analytical Technology (PAT) to monitor Maytansinoid conjugation to modified antibodies: Implications in establishing robust processes for manufacturing disulfide-linked immunoconjugates Ian M. Schwartz, Sanjiv Gohain, Dana C. Pentia, Godfrey Amphlett, Deborah H. Meshulam, Gennady Malin | |
Symposium Grid -- Division of Biochemical Technology -- Session Listing
The 234th ACS National Meeting, Boston, MA, August 19-23, 2007