Using an automated cell culture analyzer in small scale CHO fed batch mAb production

Exploring the limits of conventional small scale CHO fed batch for accelerated on demand monoclonal antibody production

Abstract
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 cellspecific 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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BioProfile FLEX2 combines MicroSensor™ Card technology with optical measurement and freezing point osmometry for an automated analyzis of a full 16 cell culture test menu. The analyzer eliminates chemistry sensor maintenance, has a high analyzer speed, and minimal sample volume.