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Wei Gu, Ph.D.

Group leader at Morphotek

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Collaboration between Eisai and Thermo Fisher Scientific

EISAI Wei Gu, Jennifer Long, Eric Evans & Frank Lee

THERMO FISHER Jamie LaPierre and Andy Campbell

The development of a custom production medium platform has several benefits for a biologic drug development process: 1) freedom to optimize the production medium platform for obtaining a robust cell culture process specific for cell lines; 2) better understand the effect of production medium platform and production process on protein characteristics; 3) COGS reduction .  Previously, Eisai and Thermo Fisher Scientific entered into a collaboration to achieve this goal.  In stage I, two large DOE screening studies were performed in shake flasks, where 24 prototype basal media and 2 prototype feeds were evaluated with two Eisai cell lines, and the other with 3 modified prototype basal media and 8 modified prototype feeds (tested with the addition of one new feed supplement) on seven Eisai cell lines.  After extensive data analysis for culture performance, production titer, and spent medium analysis, one prototype set of basal medium (BM1), feed (Feed6), and feed supplement was selected for further evaluation in bioreactors.  Numerous runs at 2L were conducted to optimize feeding strategy (e.g. feeding methodology, feeding rate, and feeding duration), operation conditions (e.g. pH set point with dead band and agitation speed), and a more concentrated Feed6 formula for minimizing the total feeding volume.  The optimized condition was robustly further scaled up from 2L to 10L with same production level.  In conclusion, the optimized production medium and feed platform could robustly produce monoclonal antibody under optimal conditions exceeding the third party’s production medium platform with comparable protein characterization, while improving COGs and freedom for further optimization.  The AGT format of this custom medium platform is currently in evaluation for manufacturability.

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