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Marks the CDMO’s second plant in the country
WuXi STA—a subsidiary of WuXi AppTec and a contract development and manufacturing organization (CDMO) serving the life sciences industry—has opened another high-potency active pharmaceutical ingredient (HPAPI) plant at its Changzhou site in Jiangsu, China. The new facility is expected to help meet the growing demand for high-potency API process R&D and manufacturing services.
The new HP plant features reactors from 250 L to 3,000 L, prep-HPLC systems, and a 108 square-foot (10 square-meter) tray lyophilizer, as well as flow chemistry and milling technologies. The new plant adopts advanced isolation technologies with the capability to handle potent compounds with occupational exposure limit (OEL) as low as 10 ng/m3.
Currently, the CDMO has two sites located in Shanghai Jinshan and Changzhou, China to support the process development and manufacture of HPAPIs. These two facilities are equipped with multiple HP process R&D and analytical labs, kilo labs, and three plants along with various process technologies, including prep-HPLC, milling, and flow chemistry, providing customers a dual supply chain to meet their HPAPI needs, from preclinical to commercial.
Alongside HPAPI, WuXi STA’s Changzhou site is capable of handling the process development and manufacturing services for linkers, oligonucleotides, and peptides, which helps provide a flexible and efficient solution for companies looking to develop therapies made of various complex conjugate modalities.