STA Pharmaceutical Co., Ltd (STA) — a WuXi AppTec subsidiary and the leading open-access R&D capability and technology platform for small molecule process development and manufacturing — announces that its new integrated R&D and commercial site, Changzhou, has expanded to 200 process R&D scientists and added a new pilot plant recently.
The site, which was officially opened in March 2016, has grown to more than 200 scientific personal including 160 process chemists, 40 analytical chemists and a special group of crystallisation technology engineers — having been trained for more than a year at the company’s Shanghai R&D facility.
The 10,000 m2 R&D centre currently has 24 standard process chemistry labs, a non-GMP kilo lab, a crystallisation lab and a process safety lab; 24 more process chemistry labs, hydrogenation labs as well as a catalysis lab will be added in Changzhou by the end of 2017.
As of January 2017, the Changzhou site has 60 reactors with a total reactor volume of 290 m3. The first commercial plant opened a year ago with milling system recently installed. A new pilot plant started operation in November 2016 with 40 reactors ranging from 250–5000 L. In 2017, one more commercial plant will be installed – nearly doubling reactor volume in Changzhou to 490 m3.
The Changzhou site is being built in stages and on completion will include more than 500 scientists and 1500 m3 of total reactor volume.
“The plan is now to grow the R&D teams to closer to 300 scientists — 230 process chemists and 70 analytical chemists by the end of 2017,” commented Youchu Wang, Head of R&D at the Changzhou site.
The Changzhou site already has more than 40 active pharma and biotech customers – 90% from the United States and Europe – with more than 60 APIs and/or intermediates under development, and already one NCE in commercial production.
“The advantage of having an integrated site like this is that for customers we can more easily transfer projects from R&D into the plant,” Minzhang Chen, CEO of STA added: “It is a state-of-the-art facility that will be amongst the most advanced of any CDMO globally.”
The CFDA approved the site in October 2016 and an FDA inspection is anticipated in the first half of 2017.