| BIOT | Tuesday, 12 September 2006 | ||
8:00 AM-11:20 AM Hilton San Francisco -- Imperial A Ballroom, Oral | |||
FDA Symposium: Process Development and Validation | |||
| Organizers: | Gail Sofer Keith Webber | ||
| 8:00 AM | To Be Determined Vicki Hindle, Richard Love | ||
| 8:20 AM | 124 | A regulatory paradigm to encourage innovation Keith Webber | |
| 8:40 AM | 125 | Meeting expectations for process validation Peter W. Wojciechowski | |
| 9:00 AM | 126 | Host cell DNA quantitation in biological pharmaceuticals Karin Anderson, Barbara Jedrzkiewicz, Mark Leonard | |
| 9:20 AM | 127 | Virus safety evaluation of Biopharmaceuticals for clinical trials: Concepts for a risk-based approach Annemarie Möritz | |
| 9:40 AM | Intermission | ||
| 10:00 AM | 128 | Establishing robust low pH retroviral inactivation conditions for development and marketed products Lenore Norling, Qi Chen, Greg Blank, Karen Shuman, Bin Yang | |
| 10:20 AM | 129 | Applying modular virus validation to large virus filtration Sherrie Curtis, Qi Chen | |
| 10:40 AM | 130 | Performance of small virus filters during extensive processing Kurt Brorson, Scott Lute, Mark Bailey | |
| 11:00 AM | 131 | Particulates in biotechnology products Subramanian Muthukkumar | |
Symposium Grid -- Division of Biochemical Technology -- Session Listing
Symposium Grid -- Biotech -- Session Listing
The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006