HJB - Your Trusted Biologics CDMO Partner

HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB

HJB - Your Trusted Biologics CDMO Partner

Cn
CASE STUDY

Fed-batch Process Change to Intensified Fed-batch Process

HJB intensified fed-batch performance

USP case4.png

Compared to FB, IFB can significantly increase process output while maintaining product comparability. The iFB process is successfully scaled up to 200L~2000L in GMP production.


Case

Background

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

Result

Developed and locked IFB process using our standard platform within 3 months from receiving the clones.

IFB process increased process output by > 80% when compared to fed-batch. Product quality were comparable between IFB and FB. The IFB process was successfully scaled up to 2000L in GMP manufacturing. Process changes were approved by CDE and FDA.

usp case 4.png




CASE STUDY