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Technologies to Improve Cell Line Development and Engineering

Presented at: Cambridge HealthTech PepTalk Conference San Diego, CA, January 14, 2009

One of the critical activities for decreasing the time for moving a biologic product from candidate selection to first in human clinical trials is the rapid generation of a stable high expressing production cell line. Technologies that can enable this rapid development include expression vectors with elements that increase transcription or translation of the linked recombinant gene, pre-adapted host cell lines, and high throughput screening methods for optimizing media composition to improve bioreactor performance and increase volumetric productivity. Strategies for achieving rapid cell line development and reducing overall development costs are addressed along with an assessment of the risks and strategic impact of short cuts taken early in development on later stage production, partnering opportunities, product valuation, and regulatory acceptance.