By the end of 2017, company plans to increase to 230 process chemists and 70 analytical chemists.
STA Pharmaceutical – a WuXi AppTec subsidiary – has announced that its new integrated R&D and commercial site, Changzhou, has expanded to 200 process R&D scientists and has added a new pilot plant.
The site, which was officially opened in March 2016, has grown to over 200 scientific personnel including 160 process chemists, 40 analytical chemists, and a special group of crystallization technology engineers - having been trained for over one year at the company’s Shanghai R&D facility. The 10,000-m2 R&D center currently has 24 standard process chemistry labs, a non-GMP kilo lab, a crystallization lab and a process safety lab. Twenty four 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 L to 5,000 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 over 40 active pharma and biotech customers – 90% from the US 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,” added Minzhang Chen, CEO of STA, “It is a state-of-the-art facility, which 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.