Background

A case of fed-batch process change to perfusion process. The productivity need to be increased significantly with comparable or better quality and accelerated the progress.

Result

Developed and locked perfusion process using our standard platform in 3 months. Successful scaling up to 300L GMP manufacturing directly with highly comparable growth, productivity and product qualities. Process changes were approved by regulators.

The product produced increased by 7.5 times compared to the original process.