WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO), announced the opening of its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. This new facility allows WuXi STA to extend its drug product capacity and capabilities.
With this new facility, WuXi STA is well positioned to provide an integrated R&D and manufacturing network for high potency active pharmaceutical ingredients (HPAPI) and drug product from preclinical to commercial manufacturing. Specifically, this facility will complement the services and offerings of WuXi STA's existing HPAPI facilities in Changzhou and Shanghai Jinshan, which are near Wuxi city. Furthermore, WuXi STA is slated to open a new HP sterile parenteral production plant in Q3 2023 at the WuXi campus.
The containment performance target (CPT) of this new HP oral drug manufacturing facility meets the control requirements of occupational exposure limit (OEL) as low as nanogram per cubic meter level. The facility offers multiple formulation processes, including wet and dry granulation, tablet compression and coating, as well as capsule filling, with an annual production capacity of 400 million tablets and 200 million capsules.