WuXi Biologics a Contract Research, Development and Manufacturing Organisation (CRDMO), has recently received Good Manufacturing Practice (GMP) certifications from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its manufacturing facilities in Wuxi Drug Product Facility 5 (DP5) and the Drug Product Packaging Center (DPPC). The approvals cover the commercial manufacturing of an ophthalmic biologic, further strengthening the company’s end-to-end biologics manufacturing capabilities.

Under this approval, the company will provide integrated manufacturing services for the ophthalmic biologic, encompassing both drug substance and drug product production. The certification followed a four-day MHRA inspection, during which both facilities successfully met regulatory requirements with no critical findings, underscoring the robustness of WuXi Biologics’ quality management and compliance systems.

DP5 is WuXi Biologics’ first commercial Pre-Filled Syringe (PFS) manufacturing facility, offering industry-leading solutions across both clinical and commercial production. The facility supports a wide range of biologic formats and drug-device combination products. Meanwhile, DPPC delivers end-to-end customised packaging services, fully compliant with international traceability and coding regulations, supporting global market requirements.

Commenting on the development, Dr. Chris Chen, CEO of WuXi Biologics, said, “The MHRA GMP certification reflects our unwavering commitment to maintaining the highest global quality standards. The quality is central to ensuring patient safety and product efficacy, adding that WuXi Biologics’ 100 percent success rate in regulatory inspections highlights its focus on operational excellence and efficiency in commercial manufacturing.”

Both DP5 and DPPC have previously received approvals from multiple major global regulatory authorities for the manufacture of various biologic therapies. WuXi Biologics’ global drug product manufacturing capacity now exceeds 100 million units per year, covering liquid and lyophilised formulations, as well as advanced delivery systems, including innovative dual-chamber formats.