The European Medicines Agency (EMA) has completed the Pre-Approval Inspection (PAI) of Wuxi Biologics’ cGMP drug substance (DS) and drug product (DP) manufacturing facilities for the production of TaiMed Biologics’ Trogarzo with no critical findings. WuXi Biologics will submit responses to the EMA inspection report in March 2019 and expects to obtain GMP certification for its facilities in May 2019.
 
According to the company, this is the first inspection of its kind in China. Upon completion of this inspection, WuXi Biologics will become the first cGMP biologics DS facility, the first cGMP biologics DP facility and the first cGMP cell banking facility in China to be approved by the EMA for commercial manufacturing. The DS and DP facilities also made headlines in March 2018 for being the first in China to pass the U.S. FDA inspection enabling the facilities to supply biologics globally.
 
“We are excited about this inspection result, which manifests our world-class quality system that meets global quality standards. We are thankful to our global clients who trust WuXi Biologics and to our staffs who tirelessly strive for excellence in quality,” said Chris Chen, chief executive officer, WuXi Biologics. “WuXi Biologics is committed to the continued expansion of our global manufacturing footprint, of the highest quality, as underlined by the recent FDA and EMA inspections. This result further allows us to expedite our ‘Follow-the-Molecule’ strategy for our clients, and continue to accelerate and transform how biologics are discovered, developed and manufactured. More high quality biologics will surely benefit patients globally.”