WuXi Biologics Receives Manufacturing License from German Health Authorities

WuXi Biologics has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany.

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 areas of cGMP manufacturing required for receiving the permit, as well as 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 scheduled to begin commercial manufacturing of a key product next week.

WuXi Biologics acquired the drug product manufacturing facility, medical devices and supplies in Leverkusen from Bayer in January 2020 and took over plant operations in April 2020. It took 12 months to assemble the comprehensive manufacturing, quality and engineering team of more than 200 employees, conduct all facility qualifications and startup activities to obtain the License of Manufacturing Permit. 

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."