Core Viewpoint - WuXi Biologics has received GMP certifications from the UK MHRA for its Drug Product Facility 5 and Drug Product Packaging Center, affirming its capabilities in commercial manufacturing of an ophthalmic biologic [1][2]. Group 1: Certification and Compliance - The Drug Product Facility 5 (DP5) and Drug Product Packaging Center (DPPC) successfully passed a four-day inspection by MHRA with no critical findings, highlighting the company's robust quality and compliance systems [2]. - Both facilities are now certified for GMP-compliant manufacturing, which is essential for global operations in the biopharmaceutical industry [1][2]. Group 2: Manufacturing Capabilities - DP5 is WuXi Biologics' first commercial pre-filled syringe (PFS) manufacturing facility, offering industry-leading solutions for both clinical and commercial production [3]. - DPPC provides end-to-end customized packaging services that comply with international traceability code requirements, enhancing the company's service offerings [3]. - The global capacity for drug product manufacturing exceeds 100 million units per year, including various formulations and drug-device combination products [3]. Group 3: Quality Assurance and Track Record - WuXi Biologics has a proven track record with 46 successful regulatory inspections, including 22 by the FDA and EMA, and holds 136 facility license approvals [4]. - The company maintains a 100% pass rate for FDA Pre-License Inspections and has undergone over 1,800 GMP quality audits by global clients [4]. - Currently, WuXi Biologics operates 15 GMP-certified drug substance and drug product facilities, reinforcing its commitment to quality and compliance [4].