Monday, November 9, 2009 - 8:50 AM
S9
Characterization of Large-scale Fermenters and Cell Culture Bioreactors
Tom Kelleher, Global Process Engineering and Process Development, Amgen, one Amgen Ctr Way, Mail stop 30w-3-A, Thousand Oaks, CA 91320
Large-scale fermentations and cell culture systems continue to be a core technology for the cost-effective production of complex biologicals and therapeutics. Formal characterization of microbial fermentations and mammalian cell culture is a growing expectation of regulatory authorities, particularly for therapeutic products. Characterization involves the deliberate manipulation of operational parameters to determine the resultant impact to process outputs and product quality. Process understanding obtained by characterization pays long-term dividends in terms of process robustness and assured product quality. As we move toward global acceptance of quality-by-design, the cost and safety issues associated with uncharacterized culture conditions are economically unacceptable. This presentation will consider some best practices for the process characterization of fermentation and cell culture.
See more of Microbial culture scale up, manufacturing, and process characterization
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See more of RAFT VIII (November 8 - 11, 2009)
See more of Invited Oral Papers
See more of RAFT VIII (November 8 - 11, 2009)