Oligonucleotide API manufacturing facility
STA Pharmaceutical (STA), a subsidiary of WuXi AppTec, opened its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China, in January 2020.
The facility will serve as an integrated platform to support the development of oligonucleotide APIs from the preclinical phase to commercial-scale manufacturing.
The manufacturing facility covers an area of more than 30,000ft² and is at WuXi STA’s site in Changzhou.
Oligonucleotide APIs up to 1mol / synthesis run will be in production at the facility, with the manufacture of various oligonucleotides, including RNA, DNA, peptide conjugates (PPMO) and morpholino oligonucleotide (PMO).
STA will also leverage its small molecule process chemistry organisation to support the development of next-generation oligonucleotide manufacturing technology.
STA opened Changzhou campus in early 2016 to expedite the development and commercialisation of products to meet customer demand.
Changzhou site passed multiple inspections conducted by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA).
The campus employs more than 200 scientists and is expected to add 1,000m3 of reactor volume. STA plans to increase the workforce at the site to more than 500 scientists and add seven multi-functional plants in the near feature. The 39-acre site will allow STA to achieve a two-fold expansion of its research and development (R&D) capacity and increase its manufacturing capabilities up to four times.
STA is developing Changzhou site in multiple phases. The campus houses an R&D building, administration building, a large-scale manufacturing plant, supporting units and additional structures.
The site supports the peptide process R&D and manufacturing of oligonucleotides, small molecules and peptides from laboratory to commercial scales.
Wuxi STA uses its small-molecule CMC (chemical, manufacturing, and control) technology to provide a one-stop platform for oligonucleotide innovators.
Integrated Changzhou campus successfully cleared two Food and Drug Administration (FDA) inspections in 2018 and 2019, with the first completed in May 2018 and the second in July 2019.
The existing facility comprises AKTA OligoPilot™ 100 (Synthesis), AKTA Avant 150 (Purification), AKTA crossflow (Ultra-Filtration) and laboratory to cGMP production scale freeze dryer. The company uses analytical techniques such as UPLC / MS, LC-MS, HPLC, UPLC, LC-MS / MS, GC / MS and ICP-MS.
STA is a pharmaceutical contract development and manufacturing organisation (CDMO), providing solutions and services for small molecule for APIs and finished dosage forms.
The firm has commercial drug product manufacturing capabilities. It performs clinical batches manufacturing, primary and secondary packaging and labelling. Currently, the company has operations in China and the US.
Based in Shanghai, the company employs more than 1,000 highly skilled research scientists who are involved in route scouting, process development, and developing control strategy for intermediates, Regulatory Starting Materials (RSMs) and APIs.
Wuxi STA’s manufacturing facility in Shanghai Jinshan has a reactor volume of 400m³. The facility has received approvals from eight global regulatory agencies to undertake the production of APIs and advanced intermediates to date.
Regulatory bodies include the US FDA, the European Medicines Agency (EMA), the China Food and Drug Administration (CFDA), Australia’s Therapeutic Goods Administration (TGA), Swissmedic, Health Canada, Japan’s MHLW and New Zealand’s MPI.
STA merged with WuXi AppTec’s Pharmaceutical Development Services (PDS) division in July 2017.
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