The FASTEC (Frozen Accelerated Seed Train for Execution of a Campaign) approachhas been developed and implemented in place of a traditional seed train approach toinitiate CHO cell culture clinical manufacturing campaigns. This approach involvescultivating cells to high density in a perfusion bioreactor, and cryopreserving cellsin multiple disposable bags called FROSTIs (Frozen Seed Train Intermediates).Each run for a manufacturing campaign would then come from a thaw of one or moreof these cryopreserved bags directly into the inoculum train, followed by fed-batchproduction. The datasets collected thus far demonstrate acceptable performance fromFASTEC runs compared to the traditional seed train process. This presentation willhighlight key process parameters impacting FROSTI thaw recovery and share findingsaround FROSTI bag design, handling and integrity evaluation. Taken together theseconsiderations enable further process improvements leading to design of a robustFASTEC process for future commercial implementation.

Recent process considerations linked to frozen accelerated seed train implementation

247th National Meeting (2014)

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