The new integrated R&D and commercial site has expanded to 200 R&D scientists and a new pilot plant has been added
The facility in Changzhou, China
STA Pharmaceutical's Changzhou site, which was officially opened in March 2016, has grown to over 200 scientific personal including 160 process chemists, 40 analytical chemists and a special group of crystallisation technology engineers. They have been trained for over one 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 facility, a crystallisation lab and a process safety lab. In addition, a process chemistry-, hydrogenation- and a catalysis lab will be added in Changzhou by the end of 2017.
The Changzhou site is being built in stages and on completion will include more than 500 scientists and 1,500 m3 of total reactor volume.
Youchu Wang, Head of R&D at the Changzhou site, said:
“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.”
As of January 2017, the 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 litres to 5,000. In 2017, one more commercial plant will be installed – nearly doubling reactor volume to 490 m3.
The company says that the Changzhou site already has over 40 active pharma and biotech customers – 90% from the United States and Europe – with more than 60 APIs and/or intermediates under development and one NCE in commercial production.
Minzhang Chen, CEO of STA, said:
“The advantage of having an integrated site is that we can more easily transfer projects from R&D into the plant.”
The China Food and Drug Administration (CFDA) approved the site in October 2016 and an FDA inspection is anticipated in the first half of 2017.
STA Pharmaceutical Co is a WuXi AppTec subsidiary. It is an open-access R&D capability and technology platform for small molecule process development and manufacturing.