EMA Completed Pre-Approval Inspection of cGMP DS and DP Facilities for Trogarzo™ at WuXi Biologics WuXi Biologics completed EMA GMP Inspection, the first biologics company in China
SHANGHAI, February 19, 2019 –WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today 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. 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.
This is the first such inspection of its kind in China, marking yet another critical milestone for WuXi Biologics, further endorsing the quality operations and the reputation of the company as a global leading biomanufacturing player. Upon completion of this inspection, WuXi Biologics will be honored to 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. 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,” commented Dr. Chris Chen, CEO of 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 ‘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.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. As of June 30, 2018, there were a total of 187 integrated projects, including 98 projects in pre-clinical development stage, 78 projects in early-phase (phase I and II) clinical development, 10 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.