WuXi Biologics Received First GMP manufacturing authorization outside of China

26 July 2021 | Monday | News

WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility
WuXi Biologics Drug Product facility (DP7) in Leverkusen, Germany

WuXi Biologics Drug Product facility (DP7) in Leverkusen, Germany

  • First GMP manufacturing authorization outside of China, validating WuXi Biologics' world-class quality system
  • Only 12 months from facility qualification to licensure demonstrating global adoption of "WuXi Biologics Speed"

WuXi Biologics , a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that Premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries


The six-day inspection was conducted by five inspectors from the Health Authority of Cologne District Government (Bezirksregierung Köln) and other regional inspectorates. The scope of the inspections comprised not only the areas of cGMP manufacturing required for receiving the permit, but also commercial production approval. The inspection covered quality systems, documents and training, facilities, utilities and equipment qualifications, aseptic DP production, material and supplier management, QC Labs, as well as electronic systems and data integrity. The facility is slated to begin commercial manufacturing of a key product next week.

Dr. Chris Chen, CEO of WuXi Biologics, said, "We're pleased that DP7 facility in Leverkusen, one of the cornerstones of our Global Dual Sourcing strategy, successfully passed the GMP inspection for biologics commercial manufacturing from an EU regulatory agency. This license represents another remarkable milestone in our efforts to establish premier-quality operations on a global scale. We will continue to strictly adhere to the quality standards set forth by the health authorities and to produce urgently needed biologics for the benefit of patients worldwide."

In January 2020, WuXi Biologics announced the acquisition of the drug product manufacturing facility in Leverkusen, Germany from Bayer. WuXi Biologics took over the plant operations in April 2020. Despite the challenges brought on by the COVID-19 pandemic, it only took 12 months to assemble the comprehensive manufacturing, quality and engineering team of over 200 employees, conduct all facility qualifications and startup activities to obtain the License of Manufacturing Permit.

"We are extremely proud of the effort by our dedicated staff in Leverkusen to obtain the permit despite all the restrictions put in place during the global pandemic, and it shows their unwavering commitment to accomplish this task at WuXi Bio Speed while maintaining WuXi Bio Quality," added Dr. Chen.


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