Research & Development
WuXi Biologics completes US FDA Pre-License Inspection and routine GMP inspection
7 April 2021 -

WuXi Biologics (2269.HK), a global company with open-access biologics technology platforms, announced on Tuesday that it has completed both a Pre-License Inspection and a routine GMP inspection by the United States Food and Drug Administration (FDA).

The inspection concentrated on the two different innovative biologics produced at the firm's facilities DP1 in Wuxi, China, including MFG1, MFG2. During the 15 working day inspections, nine inspectors assessed the manufacturing, raw material, warehousing, laboratory, equipment, utilities and quality systems.

Dr Chris Chen, WuXi Biologics CEO, said, 'I'm pleased that the FDA inspections at our Wuxi sites were completed successfully once again, marking yet another milestone in our capability to perform late-stage clinical and commercial manufacturing for our global partners. Recent history of passing regulatory inspections has laid a solid foundation for our continuous expansion of manufacturing capacities and capabilities as we are committed to providing a global dual source supply chain supported by our world-class quality system. Through our robust manufacturing supply network, we will continue to effectively and efficiently bring biologics into the clinic and to the market for our global partners to benefit patients worldwide.'



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