WuXi Biologics has announced that the European Medicines Agency (EMA) has completed the pre-approval inspection (PAI) of the company's cGMP drug substance (DS) and drug product (DP) manufacturing facilities for the production of TaiMed Biologics' Trogarzo with no critical findings.
For WuXi Bio, this is a critical milestone as the EMA inspection is the first of its kind in China.
The Chinese CDMO said it will submit responses to the EMA inspection report in March this year and expects to obtain GMP certification for its facilities two months later.
CEO, Dr Chris Chen, commented: "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."
cGMP facilitites
Upon completion of the inspection, WuXi Bio will have 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.
Wuxi Bio's DS and DP facilities made headlines in March 2018 for being the first in China to pass the US FDA inspection enabling the facilities to supply biologics globally.
"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,' Chen said, adding that this result further allows Wuxi Bio to expedite its 'Follow-the-Molecule' strategy for its clients.