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.
