Less than a year after it set up shop at an R&D and cGMP manufacturing site in Changzhou, China, WuXi AppTec subsidiary SynTheAll Pharmaceutical (STA) has already bulked up with a new pilot plant and a fresh batch of R&D scientists that were trained at the company’s R&D site in Shanghai.
STA said in a release last week that with the additions the company now has 200 process R&D scientists as well as the new plant. That includes 160 process chemists, 40 analytical chemists and a special group of crystallization technology engineers.
The 10,000-square-meter facility officially opened in March 2016. It currently has 24 standard process chemistry labs, a non-GMP kilo lab, a crystallization lab and a process safety lab. Another 24 process chemistry labs, hydrogenation labs and a catalysis lab will be added by the end of 2017, the company said.
The Changzhou site is being built in stages but when all is said and done, it will include more than 500 scientists and 1,500 cubic meters of reactor volume. It currently has more than five dozen APIs and/or intermediates under development and one NCE in commercial production.
China’s FDA approved the site in October 2016 and the U.S. FDA is expected to inspect the facilities in the first half of this year, the company said.
The China and U.S.-based WuXi in 2015 sold 6% of the business to institutional investors in anticipation of raising $80 million to help with the expansion.
STA is not part of WuXi's biologics operations, which the company also is expanding in Suzhou. In 2015, it said it would invest about $100 million in a two-year project to double a biologics facility there.