KBI Biopharma and Selexis SA Appoint J.D. Mowery as CEO
Read MoreMay 2022
Séverine Fagète, PhD, Vice President Cell Line Services
In the field of therapeutic antibody production, diversification of fed-batch strategies is flourishing in response to the market demand. All manufacturing approaches tend to follow the generally accepted dogma of increasing titer since it directly increases manufacturing output. While titer is influenced by the biomass (expressed as IVCD), the culture time and the cell specific productivity (qP), we changed independently each of these parameters to tune our process strategy towards adapted solutions to individual manufacturing needs. To do so, we worked separately on the increase of the IVCD as high seeding fed-batch capacity. Yet, as intensified fed-batch may not always be possible due to limited facility operational mode, we also separately increased the qP with the addition of specific media additives. Both strategies improved titer by 100% in 14 days relative to the standard fed-batch process with moderate and acceptable changes in product quality attributes. Since intensified fed-batch could rival the cell-specific productivity of a conventional fed-batch, we developed novel hybrid strategies to either allow for acceptable seeding densities without compromising productivity, or alternatively, to push the productivity the furthest in order to reduce timelines.
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For more than 20 years, Selexis has been at the forefront of helping the biopharmaceutical industry advance life-saving monoclonal antibodies through all the steps from IND filling, clinical phases, to market launch and commericialization.
At Selexis, we believe in the promise of newer biologics and have committed significant resources to ensure our SUREtechnology Platform™ can meet the new expression challenges that these difficult-to-express proteins present.
We are proud of the role that Selexis’ cell line technology is playing in helping to deliver on the promise of bispecifics, which is a rapidly expanding class of drugs showing impressive results in multiple clinical trials.
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