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New plant will meet the growing demand for high-potency API process R&D and manufacturing services.
June 30, 2022
By: Tim Wright
Editor-in-Chief, Contract Pharma
WuXi STA, a WuXi AppTec company, has opened another high-potency API (HPAPI) plant at its Changzhou site located in Jiangsu, China. The new plant will meet the growing demand for high-potency API process R&D and manufacturing services and consists of reactors from 250 L to 3,000 L, prep-HPLC systems, a 10 square meter tray lyophilizer, as well as flow chemistry and milling technologies. WuXi STA’s most current plant adopts advanced isolation technologies with the capability to handle potent compounds with Occupational Exposure Limit (OEL) as low as 10 ng/m3. Currently, WuXi STA has two sites located in Shanghai Jinshan and Changzhou, China to support the process development and manufacture of high-potency APIs. These two facilities are equipped with multiple HP process R&D and analytical labs, kilo labs and three plants along with process technologies such as prep-HPLC, milling, flow chemistry, etc., providing customers a dual supply chain to meet their HPAPI needs from preclinical to commercial. WuXi STA’s Changzhou site is capable of handling the process development and manufacturing services for linkers, oligonucleotides and peptides, providing a unique “one-stop” flexible and efficient solution to companies developing therapies made of various complex conjugate modalities.
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