Seed expansion in biopharm manufacturing requires numerous shake flask passages starting with vial thaw to inoculate wave bags or bioreactors. This process can take anywhere from 3 to 6 weeks of manufacturing facility time. The time in facility cannot be reduced because traditional working cell banks (or starting vials) are constrained by their volume (1-5mls) and lower typical (15-30 *10<sup>6</sup> cells/ml) frozen cell concentrations. As the number of commercial Biopharm assets continuous to grow and with limited global manufacturing facility capacity, there is a clear need to increase the throughput for both existing and greenfield manufacturing facilities. By intensifying the concentration and significantly increasing the volume of the frozen cell suspension, seed expansion can be accelerated, whereby, bioreactors or wave bags are directly inoculated from high cell density bags (considered as a process intermediate). This work aims to highlight the successes and challenges with generating and thawing high cell density cryobags including longer term cryobag storage stability studies. In summary, the biopharm manufacturing facility of the future could look very different from the one today with the deployment of high cell density cryobags supporting enhanced biopharm manufacturing facility utilization.

Enhanced biopharm manufacturing facility utilization via the use of larger volume and higher cell density bags to initiate seed expansion

255th National Meeting (2018)

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