HJB’s GMP facility is designed, built, and operated in compliance to the FDA, EMA and NMPA cGMP requirements, which has been endorsed with several rounds of rigorous audits by clients and 3rd party. We offer 50L~2000L scale cell culture and drug substance (mAb, fusion protein) manufacturing with fed-batch or perfusion mode. More than 30 batches and over 20 projects have been successfully delivered, many of which have already entered into clinical trials in US and China.
The GMP factory is constructed with the patented modular T-BLOCTM design concept, which is flexible, expandable, and reconfigurable with low cost of ownership. Product safety and process robustness is built into the facility design, i.e. regional isolation of upstream and downstream pre-viral and post viral. The facility also features single-use / disposable technology from solution preparation, cell culture to chromatography and UF/DF, which significantly drives down product changeover time and eliminates cross contamination risk.