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Manufacturing Base

DS Facility Our DS facility is designed in compliance with the requirements of FDA, EMA, and NMPA. Two independent fermentation units, with a total area of 4,500 m2, satisfy the needs of pilot-scale and commercial manufacture. 3× 200 L Sartorius disposable bioreactor lines support our pre-clinical process development, pilot-scale manufacture, and conduct of Phase I and II clinical trials. Over 100 batches of pre-clinical and clinical trial materials, including monospecific antibodies, bispecific antibodies, and fusion proteins, have been successfully manufactured. For commercialization, 1× 1000 L Sartorius disposable bioreactor line and upcoming 1× 5000 L stainless steel bioreactor line assure the successful production. A GMP-compliant quality management system ensures the quality of 100+ kg of antibody products manufactured per year meeting the IND and BLA requirements in China and the U.S.

DP Facility Our filling line and lyophilization line, also designed in compliance with the requirements of FDA, EMA, and NMPA, enable aseptic production of high-quality drug products for clinical trials and commercial use. Notably, the critical areas of the filling line achieve Class A cleanliness with laminar airflow system, and the surrounding areas, including the non-critical areas of capping (Class C cleanliness) and filling (Class B cleanliness), vial washing area (Class C cleanliness), and instrument sterilization area (Class C cleanliness), also provide environmental assurance for a successful production. With our strong GMP-compliant capability in R&D and DS and DP manufacture, and sophisticated GMP management and manufacture experiences, we are competent to fast track our products from R&D to BLA, maximally reduce the risks and costs from process and manufacture site changes, and make our products more commercially competitive.

DS Facility