WuXi Biologics facilities receive UK GMP certification
WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO), said two of its manufacturing facilities in Wuxi, China, have received Good Manufacturing Practice certification from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for commercial production of an ophthalmic biologic.
The certification covers Drug Product Facility 5, which manufactures prefilled syringes, and the Drug Product Packaging Center, which provides commercial packaging services, according to the company. WuXi Biologics said it provides end-to-end manufacturing services for the ophthalmic biologic, including both drug substance and drug product.
The CRDMO said the four-day MHRA inspection concluded with no critical findings, which it said supports its ability to provide GMP-compliant commercial manufacturing for global markets.
Drug Product Facility 5 is the company’s first commercial prefilled syringe manufacturing site and supports both clinical and commercial production, according to the company. The packaging center provides customized packaging services reportedly designed to meet international traceability code requirements. Both sites have previously received approvals from other global regulatory authorities for biologic drug production.
WuXi Biologics said its global drug product manufacturing capacity exceeds 100 million units annually and includes liquid and lyophilized formulations as well as drug-device combination products.
“We are delighted to receive GMP certification from MHRA, a testament to our steadfast commitment to the highest global quality standards,” said CEO Chris Chen in a company statement.
As of the end of 2025, WuXi Biologics said it had passed 46 regulatory inspections globally, including inspections by the U.S. Food and Drug Administration and the European Medicines Agency, and holds licenses for 136 facilities. The company said it operates 15 GMP-certified drug substance and drug product facilities worldwide.