WuXi Biologics Obtains GMP Certification from UK MHRA for Commercial Manufacturing of an Ophthalmic Biologic

WUXI, China, Jan. 12, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that two of its manufacturing facilities in Wuxi –Drug Product Facility 5 (DP5) and Drug Product Packaging Center (DPPC) – have received GMP certifications from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for commercial manufacturing of an ophthalmic biologic. WuXi Biologics delivers end-to-end manufacturing services for this ophthalmic biologic, covering both drug substance and drug product.

During the four-day inspection, both facilities successfully passed MHRA's assessment with no critical findings, reaffirming WuXi Biologics' robust quality and compliance systems, and its capability to provide GMP-compliant manufacturing on a global scale.

DP5, WuXi Biologics' first commercial pre-filled syringe (PFS) manufacturing facility, delivers industry-leading PFS solutions to clients with production lines covering both clinical and commercial manufacturing. DPPC provides clients with end-to-end customized packaging services, fully compliant with international traceability code requirements. Both DP5 and DPPC have previously obtained approvals from major global regulatory authorities for the production of multiple biologic therapeutics. WuXi Biologics' global DP capacity exceeds 100 million units per year, encompassing liquid and lyophilized formulations as well as a variety of drug-device combination products, including innovative dual-chamber formats.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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 has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, has obtained 136 facility license approvals. The company also holds an industry-leading record with a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities remain the cornerstone of clients' trust.

SOURCE WuXi Biologics