Akeso is committed to establishing an excellent production facility system that meets international good manufacturing practice (GMP) standards.
Akeso’s GMP-compliant manufacturing facilities are designed and validated according to the NMPA, the FDA and the EMA regulations, and support the entire drug development process, from drug discovery to process development, GMP-compliant pilots and commercial manufacturing. Meanwhile, we conduct daily process audits and comprehensive annual audits of our production facilities to assess compliance with GMP and related quality standards.
At present, Akeso has planned a production layout in Zhongshan, Guangzhou, etc. with a planned total capacity of more than 160,000L. Upon completion, Akeso will become the biopharmaceutical enterprise with the largest intelligent production system in China.
Houses the first pharmaceutical plant in South China to use GE Healthcare FlexFactoryTM technology, which provides central control and single-use bioreactor systems, the manufacturing facility can scale up GMP-compliant production with an existing capacity of 3,500L and a filling/packaging line capacity of 6,000 vials/hour (10ml and 2ml vials).
As a key project of Guangzhou based on international first-class design concepts, the China-Singapore Guangzhou Knowledge City Biopharmaceutical Base is planned to become a demonstration base for local biomedical innovation enterprises in Guangdong. It meets the GMP requirements of FDA, EMA and NMPA for the production of biopharmaceuticals, with a total investment of over RMB 3 billion and a planned capacity of 80,000L. It is composed of three parts: Akeso Pharma Co., Ltd (Akeso Pharma), AD Pharmaceuticals (AD Pharma) and Akeso Longyue. Akeso Pharma is equipped with a complete set of Cytiva FlexFactoryTM drug production equipment, a BOSCH automatic preparation filling line, etc., with a planned total capacity of 60,000L. The first phase commenced operation with production capacity of 20,000L in March 2021, and it is mainly used for large-scale production of self-developed new biologics including开坦尼®(Cadonilimab injection).
Commercialization manufacturing base in Cuiheng, Zhongshan has a total investment of over RMB 3 billion, land area of 167 mu and construction area of 440,000 m2, as well as a total planned capacity of over 100,000L. It integrates the R&D, raw liquids production and commercialization of innovative antibody drugs. Upon completion, it will become a technologically advanced global base for the innovation, R&D and industrialization of biopharmaceuticals. The Park is divided into three phases which are scheduled to start production by the end of 2022, first quarter of 2023 and 2024 respectively.