WuXi STA Expands Oligo, HPAPI and Peptide Manufacturing in ChinaBy
WuXi STA is proceeding with a series of investments to expand oligonucleotide, high-potency active pharmaceutical ingredient (API), and peptide manufacturing at its site in Changzhou, China. Yu Lu, Vice President, Business Operations, STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, detailed the expansions at the DCAT Member Company Announcement Forum—Virtual Edition, a special online forum of the major news announcements from DCAT member companies originally to be made March 23, 2020 at DCAT Week ’20 in New York.
In January (January 2020), WuXi STA opened a large-scale, 30,000-ft2 oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. The site can manufacture oligonucleotide APIs up to 1 mol/synthesis run. With this new addition, WuXi STA can now provide process R&D, analytical and manufacturing services for oligonucleotides from preclinical to commercial scales, covering DNA, RNA, and morpholino oligonucleotides as well as a variety of oligonucleotides conjugates.
WuXi STA also opened in the first quarter of 2020 a high-potency API (HPAPI) facility at the Changzhou site, its second HPAPI facility. WuXi STA’s first HPAPI facility, located at its Shanghai Jinshan site in China, supports process R&D and kilo-scale production. The newly added HPAPI facility in Changzhou includes HPAPI labs and a pilot plant (250-L–1,000-L reactors) capable to handle APIs with occupational exposure limits down to 0.05 µg/m3.
In the peptide field, a new large-scale (up to 1,000-L synthesizer) production plant in Changzhou is to be completed by the first half of 2020 and which spans 6,400 m2 and five production lines. The expansion provides the company with an integrated peptide API platform from preclinical to commercial scales.
WuXi STA’s 39-acre campus in Changzhou currently houses one R&D center and seven plants with more than 500 scientists. The company has initiated the next phase of its expansion plan in Changzhou that will add another R&D center and eight more plants in the next few years. By 2025, the company says that the Changzhou site will span to 74 acres and will include two R&D centers with more than 1,000 scientists, 15 plants, and 400-plus reactors.