Akeso is committed to establishing an excellent production facility system that meets international good manufacturing practice (GMP) standards.
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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.
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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 Sino-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 the commenced operation with production capacity of 36,000L. 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 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).?AD Pharmaceuticals has been put into production with a total capacity up to 16,000L, mainly used for the large-scale production of innovative monoclonal antibody drugs Pulocimab and Ebronucimab, independently developed by the Company, which are expected to be approved for marketing in 2023–2024.
Akeso Greater Bay Area Technology Park 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 of the? first quarter in 2023 and the second quarter in 2024 respectively.
Akeso Global innovation Center?is situated in the Zhangjiang Headquarters Park (Youchuang Park) in Shanghai, spanning an expansive 14,000 m2?area and boasting a total construction space of 67,000 m2. With an anticipated total investment of CNY850 million, the construction is already underway. Functioning as a pivotal element in Akeso's global innovation strategy and serving as the primary driver for sustained high-speed innovation and development in the future, the Akeso Global R&D Center aligns strategically with the group's research and development objectives. Its aim is to grasp and lead the latest global research directions, with a specific focus on cutting-edge technological fields such as gene therapy, cell therapy, neurodegenerative diseases, anti-aging, and more. The center will consistently build an advanced research pipeline and establish platforms and teams for tumor microenvironment big data analysis and translational research.Using Zhangjiang as a gateway, Akeso Global innovation Center will connect with global resources, support the establishment of a world-class biopharmaceutical industry cluster in Zhangjiang, Shanghai, and drive the global expansion of innovative drugs developed in China, ultimately benefiting patients in China and across the globe.
International Clinical Research and Development Center and Translational Medicine Center will be built in the Akeso Clinical Research and Operation Asia Pacific Center. The Clinical Research and Development Center will set up National Clinical Data Center, Clinical Operations, Clinical Research, Clinical Medicine, Clinical Audit and Clinical Quality Center. The Translational Medicine Center will build Preclinical Translational Lab, and Clinical Sample Testing Lab, etc. With the establishment of the base, a more systematic and advanced comprehensive R&D center will be created.