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CASE STUDY

Fed-batch Process Change to Perfusion Process

Background

A case of process change from fed-batch to perfusion. The driver is to significantly increase productivity with comparable or better quality and to accelerate the project timeline.


Result

Developed and locked perfusion process using our standard platform within 3 months from receiving top clones.

Perfusion process increased process output by > 8X when compared to fed-batch. Product quality were comparable between perfusion and fed-batch. The perfusion process was successfully scaled up to 500L in GMP manufacturing. Process changes were approved by CDE and FDA.

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CASE STUDY