Shanghai Huaota Biopharmaceutical Co., Ltd. has its own pilot production plant that meets applicable GMP requirements. The construction area of the bulk drug substance workshop is about 870m2 with the clean rooms and controlled area of 727m2 mainly including seeding room, fermentation room, purification room, ultrafiltration room, solution preparation room, and other auxiliary function rooms. The main equipment, such as disposable stirring system, single-use bioreactor, chromatography column, etc., are provided by international first-class equipment suppliers such as GE, PALL and Sartorius. The workshop can meet the needs of maximum 1000L cell culture scale.
The area of drug production workshop is 700m2 with the clean rooms and controlled area of 578m2, mainly including cleaning and sterilization room, unpacking room, filling room, liquid dispensing room, etc. The equipment includes pulsation vacuum sterilization cabinet, pre-filled syringe filling production line (Bosch system, production capacity of 17,000 pieces/hour) and vial filling production line (Bosch system, production capacity of 12,000 pieces/hour), etc.
