#China #Wuxi #WuXi Biologics #GMP Certification #Ophthalmic Products

WuXi Biologics Receives GMP Certification from UK MHRA

In a significant milestone for the global biopharmaceutical landscape, WuXi Biologics (2269.HK), a prominent Contract Research, Development, and Manufacturing Organization (CRDMO), has proudly announced the attainment of Good Manufacturing Practice (GMP) certification from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This certification applies to their Drug Product Facility 5 (DP5) and Drug Product Packaging Center (DPPC) in Wuxi, China, for the commercial manufacturing of ophthalmic biologics.

The accomplishment came after a thorough four-day inspection conducted by MHRA, during which both facilities demonstrated their adherence to stringent quality standards with no critical findings. This reinforces WuXi Biologics' reputation for maintaining robust quality systems and compliance measures, ensuring that it can provide GMP-compliant manufacturing services globally.

State-of-the-Art Facilities

DP5 marks an essential advancement for WuXi Biologics as its first commercial pre-filled syringe (PFS) manufacturing facility. Equipped with cutting-edge production lines, DP5 caters to both clinical and commercial manufacturing needs. Meanwhile, the DPPC is designed to meet clients' needs with comprehensive packaging services that comply with international traceability code requirements.

Both facilities have previously received approvals from significant global regulatory bodies, allowing them to produce multiple biologic therapeutics. With a global drug product capacity exceeding 100 million units per year, WuXi Biologics excels in providing both liquid and lyophilized formulations, as well as various drug-device combination products, including innovative dual-chamber formats.

Commitment to Quality

Dr. Chris Chen, CEO of WuXi Biologics, shared his enthusiasm about this certification: "We are delighted to receive GMP certification from MHRA, a testament to our steadfast commitment to the highest global quality standards. Quality is fundamental to ensuring safety and efficacy. Maintaining a 100% success rate for regulatory inspections reflects our relentless pursuit of excellence and efficiency in commercial manufacturing. We will continue to build on our world-class quality system and exceptional service capabilities and enable partners to deliver life-saving treatments for patients worldwide."

WuXi Biologics prides itself on a strong track record of adhering to rigorous industry quality standards. By the end of 2025, the company had successfully undergone 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. Notably, it holds a commendable 100% pass rate for FDA Pre-License Inspection (PLI). Additionally, the company has successfully passed over 1,800 GMP quality audits conducted by global clients, including more than 230 evaluations by EU Qualified Persons.

Presently, WuXi Biologics boasts a network of 15 GMP-certified drug substance and drug product facilities worldwide. Its unwavering commitment to quality and compliance remains the cornerstone of its clients' trust, ensuring the delivery of innovative biopharmaceutical solutions to enhance patient care.

As WuXi Biologics moves forward with its operations, it remains dedicated to maintaining high standards of quality and efficiency, solidifying its role as a leader in the biopharmaceutical manufacturing sector. This new certification amplifies its ability to provide unparalleled manufacturing solutions, ultimately benefiting the health and well-being of patients across the globe.