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


Dec, 2021

HJB congratulates its client on an approval of CMC process change supplemental application filed to Chinese National Medical Products Administration (NMPA) in support of a late phase clinical trial in China.

This project was transferred to HJB in 2019. Based on the evaluation of product specifications and future clinical demands, HJB developed intensified fed-batch process which increased process output by >100% while maintaining product comparability. The process was efficiently transferred to manufacturing and the joint PD and manufacturing team successfully scaled up the process and completed two consecutive 2,000L GMP runs for DS and DP filling. 

In addition, HJB also assisted the client in drafting the CMC process change supplemental application for NMPA submission and successfully addressed all NMPA inquiries; there were no major concerns from NMPA due to the quality of the CMC package. As a result, the client has successfully obtained approval from NMPA on the process change in support of late-stage clinical studies and future commercial launch. 

Importantly, HJB has completed the manufacture capability upgrade in 2020. It has CMC laboratories, 1x200L SUB production line in the Pilot Plant and T-Bloc designed GMP plant that meets CDE, FDA and EMA cGMP standards. At present, HJB has 1x200L, 3X500L, 2X2,000L SUB DS production lines and aseptic fill/finish line using Bosch isolator technology at 200,000 DP vials/batch capacity.