WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility
WuXi Biologics has announced receiving a License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. This marks the first GMP manufacturing authorization outside of China, showcasing its global quality standards. The facility qualified in just 12 months, illustrating the speed of its operations. Following a thorough inspection by Cologne's health authorities, the DP7 facility is set to commence commercial manufacturing of a key product next week, reinforcing WuXi’s commitment to delivering quality biologics.
- Received GMP manufacturing authorization from German health authorities for the DP7 facility.
- Completed licensure in just 12 months despite COVID-19 challenges.
- Facility set to begin commercial manufacturing next week, enhancing product availability.
- None.
- 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"
LEVERKUSEN, Germany, July 26, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), 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.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients.
The company is currently conducting (as of March 22, 2021) a total of 361 integrated projects: 190 in pre-clinical development; 137 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 2 in commercial manufacturing. With a total estimated capacity at around 430,000 liters for biopharmaceutical production planned by 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will provide its biomanufacturing partners with an even more robust and premier-quality global supply chain network.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation cleaner biomanufacturing technologies and cleaner energy to enable global clients. We have also established an ESG committee led by the CEO to increase efficiency while advancing commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
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