Thursday, August 14, 2008 - 9:00 AM
S146

Antibody Production Using Mammalian Cell Culture - How High Can We Push Productivity?

Thomas Ryll, Cell Culture Development, Biogen Idec, Inc., 5200 Research Place, San Diego, CA 92122

Production of antibody drugs using mammalian cell culture has made significant progress over the last 20 years. Fed-batch processing has evolved as the dominant production mode at industrial scales of up to 15 – 20,000L operating volumes. While product concentrations in the 0.5 - 1 g/L range were considered high productivity in the early 90ties product concentrations in the range above 1 g/L is nowadays standard expectation and are typically reached at the pre-IND stage applying platform process designs with little to no optimization. More optimized fed-batch processes typically reach 2-5 g/L and more recently titers as high as 10 g/L have been reported for CHO cell culture.

 

One major driver for further improved productivity is required production capacity and associated capital costs which could better be invested in development of new products. Improved process formats with high volumetric output will enable the industry to reduce reliance of ever increasing capacity demands and associated capital investment. The presentation will focus on aspects governing fed-batch process optimization with CHO cell culture to reach product concentration in access of 10 g/L and volumetric productivities (time space yields) of 500 mg/L/d using typical manufacturing equipment. Such improved process formats will in the future reduce reliance on large capital investment needs and help development of more products dearly needed by our customers.


See more of Cell Culture and Microbial Platforms for Production of Monoclonal Antibodies and Antibody Fragments Part 1
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