BIOT 160 |
| Many groups have discussed the use of a platform process for cell culture and purification of therapeutic proteins. The typical approach involves the use of a technology transfer team as an interface between research and manufacturing, either clinical or commercial. A more entrepreneurial approach was adopted for the development of a platform process to support clinical manufacturing via collaboration among the cell culture, purification and pilot plant groups without the use of a technology transfer team. This collaborative approach allowed for a more detailed understanding of the scale-up process by all of the groups resulting in faster implementation and a higher probability of success. Effective development and implementation of the platform process required definition of a representative scale-down model based on key process parameters and key quality attributes, precursors to CPP (critical process parameters) and CQAs (critical quality attributes) early in development. Direct involvement of the pilot plant groups during development and cross-training of technical staff (cell culture and purification) identified issues (ex. equipment and logistics) and risks (ex. process limitations) which supported parallel scale-up and optimization activities early in development. This approach allowed the groups to focus on execution during the scale-up and was a key to successful and efficient deployment of the platform The presentation will include a comparison of the process performance at the bench, intermediate and pilot scales and a discussion of the appropriate modifications to the process to address engineering constraints expected at the larger scale. The presentation will also provide an overview of how a collaborative approach supported rapid scale-up (less than 6 months) from bench (3 L) to pilot scale (2 kL) purification. |
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Downstream Processing: Purification and Platform Case Studies
3:00 PM-5:30 PM, Tuesday, 12 September 2006 Hilton San Francisco -- Plaza, Oral
Division of Biochemical Technology |