German health authorities issued WuXi Biologics a License of Manufacturing Permit 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 and other regional inspectorates.
The scope of the inspections covered not only the areas of cGMP manufacturing required for receiving the permit, but also commercial production approval. The inspection looked at quality systems, documents and training, facilities, utilities and equipment qualifications, aseptic DP production, material and supplier management, QC Labs, and electronic systems and data integrity. The facility is slated to begin commercial manufacturing of a key product next week.
“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,” said Chris Chen, PhD, WuXi Biologics’ CEO. “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 Leverkusen facility from Bayer. WuXi took over the plant operations in April 2020. Despite the challenges brought on by the COVID-19 pandemic, noted Chen, it only took 12 months to assemble the manufacturing, quality, and engineering team of over 200 employees, conduct all facility qualifications and startup activities to obtain the permit.