Background
In order to significantly increase cell culture productivity to increase process output and lower cost of goods, client requests HJB to convert their Phase 1 fed-batch process to highly intensified continuous perfusion process while maintaining product comparability under aggressive timeline.
Result
Developed and locked perfusion process using our standard "Plug and Play" continuous perfusion platform within 3 months from receiving top clones.
Perfusion process increased process output by 8-15X when compared to fed-batch process using the same cell line. Further process optimization ensured that product quality was comparable between perfusion and fed-batch. The perfusion process was successfully scaled up to GMP manufacturing scale. Process changes were approved by CDE and FDA.