STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This marks WuXi STA’s establishment of a one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around the world to advance promising new oligonucleotide therapies more rapidly to market for the benefit of patients.
The new facility, with over 30,000 square feet, is located at WuXi STA’s Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers.
WuXi STA’s platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company’s industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development.
“By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide,” said Dr. Minzhang Chen, CEO of WuXi STA.