STA Pharmaceutical (WuXi STA), the subsidiary of WuXi AppTec, has celebrated the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility at its site in Changzhou, China.
The new facility, with over 30,000 square feet, can manufacture oligonucleotide APIs up to 1 mol/synthesis run.
Dr Minzhang Chen, CEO of WuXi STA, commented: “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 commercialisation of oligonucleotide drugs to benefit patients worldwide."
Nucleic acid drugs have gradually become a hot area in the global innovative drug industry, and many nucleic acid drugs have been approved by the US FDA in recent years.
The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialisation of oligonucleotide drugs
WuXi STA’s comprehensive 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 small molecule process chemistry expertise 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.
WuXi STA’s Changzhou site can now provide services involving small molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales.
During the past years, it has successfully passed multiple inspections from the FDA and the National Medical Products Administration (NMPA), adhering to the highest regulatory standards.
The Wuxi STA Changzhou Site is a state-of-the-art integrated campus. This facility successfully passed two U.S. FDA inspections in 2018 and 2019. The site includes an R&D building, a pilot-scale manufacturing plant, two commercial manufacturing plants, QC building, hydrogenation plant, supporting units and warehouses.