Production & Operation

AD Pharmaceuticals plans to build a world-class innovative biopharmaceutical industrialization production base that meets the GMP standards of the United States, European Union and China, including an R&D building, quality inspection building, drug substance production workshop, preparation workshop, warehouse, power center, etc. Currently, AD Pharmaceuticals has been fully put into production with a total capacity up to 16,000L.

 

The cell culture mainly use imported equipment from brands such as Roche, Siemens and Thermo Fisher, and the purification system includes a chromatography system, virus removal filtration system, automatic ultrafiltration system, etc. The control system of key equipment are based on Emerson's DeltaV open intelligent control platform, which can carry out centralized data management and step-by-step control, enable the automatic production of the batch process and maintain the batch-to-batch quality consistency of products.

 

The base is 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.

 

  • 25000m²

    State-of-the-art GMP facilities in compliance with the FDA, NMPA and EMA regulatory requirements.

  • 1 million / year

    Capability to produce high quality monoclonal antibody injections.

Production Equipment
  • Lisure Chromatography Systems
  • INFORS Minitron Shaker and Airtech Clean Bench
  • Lisure Ultra-Filtration System
  • 500L production- scale Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.)
  • 2000L production- scale Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.)
  • Syringe Filling Machine