Strategies for implementation of a new bioprocess container in commercial biologics manufacturing

BIOT 257

Rachael Marcklinger, rachael.marcklinger@bms.com1, Carolyn Williamson, carolyn.williamson@bms.com1, Joel Gates, joel.gates@bms.com1, Abhinav A Shukla, abhinav.shukla@bms.com1, and Steven Lee2. (1) Bioprocess Engineering, Bristol-Myers Squibb, PO BOX 4755, Syracuse, NY 13221, (2) Technical Operations, Bristol-Myers Squibb, 6000 Thompson Road, East Syracuse, NY 13057
There are numerous important aspects that must be considered when implementing a new bioprocess container into a commercial manufacturing process. These include vendor sourcing, design, review of vendor data, compatibility with process streams, and container closure integrity. Strategies to streamline implementation will be presented. A grouping rationale will be presented to minimize the testing required. Finally, several case studies will be used to highlight key aspects of this strategy.
 

Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007