A month ago, WuXi Biologics told us that it expected to receive approval from the European Medicines Agency (EMA) for the facilities by May 2019. Yesterday, the EMA provided its current good manufacturing practice (cGMP) certification ahead of this projection.
The certification concerns drug substances and drug product manufacturing facilities in Wuxi city, and cell banking facilities in Shanghai.
Both sites are used in the production of Trogarzo (ibalizumab), which is a product developed by TaiMed Biologics and marketed in the US and Europe by Theratechnologies, indicated for the treatment of HIV-1 in heavily treated adults with multidrug resistance.
“This [certification] marks yet another great milestone that WuXi Biologics has achieved and lays a solid foundation for us to significantly expand our manufacturing capacity and capabilities,” said Chris Chen, CEO of WuXi Biologics.
In order to receive EMA approval for its facilities, WuXi Biologics told us that it had submitted written responses to the agency’s request for improvement to procedures.