Background

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

Result

Developed and locked IFB process using our standard platform in 3 months. Successful scaling up to 2000L GMP manufacturing directly with highly comparable growth, productivity and product qualities. Process changes were approved by regulators.

The productivity increased by 100% and the culture time reduced by 30%.