- WuXi Biologics has received UK MHRA GMP certification for two manufacturing facilities in Wuxi for commercial production of an ophthalmic biologic.
- The approval followed a four-day inspection with no critical findings and covers end-to-end manufacturing services.
WuXi Biologics has received Good Manufacturing Practice (GMP) certification from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for two of its manufacturing facilities in Wuxi, China. The approval covers Drug Product Facility 5 (DP5) and the Drug Product Packaging Center (DPPC) for the commercial manufacture of an ophthalmic biologic.
The certification follows a four-day MHRA inspection of both sites, which concluded with no critical findings. According to the company, the approval confirms its ability to deliver GMP-compliant manufacturing services at a global level. WuXi Biologics provides end-to-end support for the ophthalmic biologic, covering both drug substance and drug product manufacturing as part of its CDMO and contract manufacturing services.
DP5 is the company’s first commercial pre-filled syringe manufacturing facility and supports both clinical and commercial production. DPPC provides customised packaging services and is compliant with international traceability code requirements. Both facilities have previously received approvals from other major regulatory authorities for the manufacture of multiple biologic products.
WuXi Biologics stated that its global drug product capacity exceeds 100 million units per year, including liquid and lyophilised formulations and a range of drug-device combination products. The company also highlighted its broader quality track record, noting that it operates 15 GMP-certified drug substance and drug product facilities worldwide.
“We are delighted to receive GMP certification from MHRA, a testament to our steadfast commitment to the highest global quality standards.”
Dr Chris Chen, CEO of WuXi Biologics
