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Remote Pre-Approval Inspection Completed by EMA on WuXi Biologics’ MFG4 Facility
Mar. 03, 2021
Remote Pre-Approval Inspection Completed by EMA on WuXi Biologics’ MFG4 Facility
Wuxi, China, March 3, 2021 – WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, today announced that the European Medicines Agency (EMA) has completed a remote Pre-Approval Inspection (PAI) on its drug substance facility (MFG4) in Wuxi city for the production of an innovative biologics of a global partner. 

This five-day inspection covered MFG4 facility’s material and production system, utilities, quality control labs, as well as quality system. This inspection also utilized WuXi Biologics’ innovative remote solutions to virtually enable due diligence, GMP audits and inspections, as well as persons-in-plant (PIP) for the first time.

"We’re pleased with another successful regulatory inspection which reaffirms WuXi Biologics’ strong commitment to offering partners a global manufacturing network of the highest standard,” commented Dr. Chris Chen, CEO of WuXi Biologics, “Through our robust manufacturing capacity and resilient supply chains, we will continue to effectively and efficiently bring biologics solutions to global partners for the benefits patients worldwide.”

Since 2017, WuXi Biologics has passed a total of six regulatory inspections conducted by FDA, EMA and ANVISA, which makes it to be the first and, to-date, the only biologics company certificated by these regulatory agencies for commercial manufacturing in China.

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. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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