WuXi STA, a global contract research development and manufacturing organization (CRDMO), opened its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. This new facility marks a milestone for WuXi STA, further extending its drug product capacity and capabilities to meet the growing demand for HP drug candidate development and manufacturing services.

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. In addition, 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.

“We are delighted to announce the opening of our first drug product manufacturing facility for high potency oral products,” said Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. “As our global partners and customers seek accelerated pathways for new drug development, WuXi STA is committed to further enhancing our integrated platform to enable more healthcare breakthroughs that benefit patients worldwide.”

In recent years, WuXi STA has established new state-of-the-art facilities to increase the company’s drug production capacity and capabilities to meet the needs of customers around the world. In August, the company announced the groundbreaking for its new pharmaceutical manufacturing campus in Middletown, Delaware, will provide formulation and development, and clinical and commercial drug product manufacturing services in phase I. Last year, WuXi STA established its first Europe-based drug product manufacturing facility in Couvet, Switzerland, which provides tablet & capsule commercial manufacturing and packaging capabilities.