BIOT 151 |
| Post-approval changes to a process present many challenges and opportunities. In this case study, significant changes were made to enhance yield and consistency. Characterization and validation studies were undertaken in order to increase process understanding and ensure that current validation standards were met. As a result, the entire cell culture process from seed train to harvest was examined, even though some stages were unchanged. Documentation, resource requirements, and the benefits of such studies will be discussed. In addition to providing documentation to support deviation resolution for manufacturing operations, a good characterization and validation strategy can facilitate multi-facility transfers, allow for robustness-enhancing optimization, and identify key parameters for next generation process versions. The knowledge gained can also be leveraged in strategies for other products. Specific examples will be given along with some of the lessons learned. |
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Upstream Processing: Advances in Cell Culture Process Development
3:00 PM-5:25 PM, Tuesday, August 21, 2007 BCEC -- 107A, Oral
Division of Biochemical Technology |