WuXi Biologics Receives GMP Conformity Assessment from the Singapore Health Sciences Authority (HSA)
Singapore, April 8, 2021 -
WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that its robotic aseptic filling facility (DP4), has received the Good Manufacturing Practice (GMP) conformity assessment from the Singapore Health Sciences Authority (HSA). This supports the company’s commitment to providing diversified and premier-quality formulation and filling capabilities that will further reinforce the company’s global manufacturing network.
With this important milestone, we proudly become the first company in China to receive recognition from the U.S. FDA, EMA, ANVISA and HSA to manufacture biologics. To date, WuXi Biologics’ facilities in Wuxi, Shanghai and Suzhou have completed ten GMP inspections conducted by these regulatory agencies.
The assessment focused on the production, quality control, release and storage operations pertaining to a biologics manufactured for a Singapore-based client. It confirms that WuXi Biologics has maintained the acceptable level of compliance with the Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/S) Guide in relation to GMP. Since its GMP launch in July 2019, DP4 has completed over 110 batches of drug product filling with the success rate of 100%.
“The recognition from HSA provides additional proof of our global premier-quality system that is built and maintained by the joint efforts of our employees and long-term trust of our clients,” commented Dr. Chris Chen, CEO of WuXi Biologics. “Robotic aseptic filling represents the most advanced filling technology in biologics manufacturing. Early adoption and becoming the few with regulatory approval by WuXi Biologics manifests our focus on using the most state-of-the-art technologies in manufacturing. In the future, we will continue to develop cutting-edge technologies to accelerate biologics discovery, development and manufacturing for the benefits of patients worldwide.”
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 March 22, 2021, there were a total of 361 integrated projects, including 190 projects in pre-clinical development stage, 137 projects in early-phase (phase I and II) clinical development, 32 projects in late-phase (phase III) development and 2 projects in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore around 430,000 liters after 2024, 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.