STA Pharma Expands Changzhou Site

STA Pharmaceutical, a WuXi AppTec subsidiary, has expanded its new integrated R&D and commercial site in Changzhou, China, to 200 process R&D scientists and added a new pilot plant.

The 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 crystallization technology engineers having been trained for over a year at the company’s Shanghai R&D facility. The 10,000 square-meter 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 cubic-meters. The first commercial plant opened a year ago with a 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 cubic-meters.

The Changzhou site is being built in stages and on completion will include more than 500 scientists and 1500 cubic-meters 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," said Youchu Wang, head of R&D at the Changzhou site.

The Changzhou site already more than 40 active pharma and biotech customers—90% from the U.S. and Europe—with more than 60 APIs and/or intermediates under development, and 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," said Minzhang Chen, chief executive officer, STA. "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.