WuXi STA, a global contract research development and manufacturing organization (CRDMO), has added additional manufacturing facilities around the world to meet the demand for drug candidate development services.
Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, stated, “As our global product 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.”
The new facility on the Wuxi city campus is the CRDMO’s first high potency (HP) oral drug product manufacturing facility. The facility is planned to have capabilities for high potency active pharmaceutical ingredients (HPAPI) from preclinical to commercial manufacturing.
Youchu Wang, senior vice president and head of STA early phase development with WuXi STA, previously told Outsourcing-Pharma that he has seen a recent demand for HPAPI from its customers in recent years. “This trend, on one hand, is the result of the proliferating emergence of anti-cancer therapy and antibody-drug conjugates,” said Wang.
He added, “With this unprecedented popularity, you can already foresee a huge manufacturing capacity gap.” Wang explained that the complex conjugates are challenging to manufacture and require special containment equipment to meet operational exposure limit (OEL). With these factors, targets often need to outsource HPAPI development and manufacturing.
Wet and dry granulation, tablet compression and coating, and capsule filling will be processed at the new facility with a production capacity of 400 million tablets and 200 million capsules. The containment performance target (CPT) of the facility meets control requirements of occupational exposure limit (OEL) as low as nanogram per cubic meter level.
WuXi STA has existing HPAPI facilities in Changzhou and Shanghai Jinshan. An additional new HP sterile parenteral production plant is scheduled to be added to the WuXi campus in late 2023.
The CRDMO announced the groundbreaking of a new pharmaceutical manufacturing campus in Middletown, Delaware, to provide formulation development alongside clinical and commercial drug product manufacturing services in phase I.
WuXi STA added a drug product manufacturing facility in Couvet, Switzerland for tablet and capsule manufacturing and packaging.