WuXi Biologics, a leading global contract research, development and manufacturing organization (CRDMO), announced that five manufacturing facilities successfully passed the Pre-License Inspection (PLI) by the US Food and Drug Administration (FDA), with no critical issues or data integrity findings. This achievement reinforces the company's perfect track record of regulatory compliance—maintaining a 100% success rate passing PLIs across all facilities.
FDA Inspection Scope and Results
The FDA's comprehensive inspection covered WuXi Biologics' quality management system and the entire production processes of multiple facilities located in Wuxi, China. The inspection encompassed two drug substance facilities (MFG1 and MFG5) and three drug product facilities (DP1, DP2 and DP5).
Of particular significance, DP5—the company's first commercial pre-filled syringes (PFS) manufacturing facility—passed its initial regulatory inspection by the FDA. This milestone will enable WuXi Biologics to provide high-quality PFS manufacturing solutions to clients worldwide, expanding the company's service capabilities in specialized drug delivery systems.
Regulatory Track Record
As of late 2024, WuXi Biologics has successfully passed 42 regulatory inspections, including 22 conducted by the EU EMA and the FDA. The company has also received 97 license approvals from regulatory agencies around the world, demonstrating its global compliance capabilities across multiple jurisdictions.
Leadership Perspective
Dr. Chris Chen, CEO of WuXi Biologics, emphasized the company's commitment to quality standards: "At WuXi Biologics, our unwavering commitment to the highest global quality standards is embedded in everything we do. Maintaining a 100% success rate for regulatory inspections is a true reflection of our relentless pursuit of excellence in building a world-class quality system that not only meets but exceeds global regulatory requirements."
Chen added that WuXi Biologics will continue "with speed and efficiency—to enable global partners in delivering life-saving treatments, with the ultimate goal of benefiting patients worldwide."
Company Operations
WuXi Biologics operates as a global CRDMO offering end-to-end solutions that enable partners to discover, develop and manufacture biologics from concept to commercialization. With over 12,000 skilled employees across China, the United States, Ireland, Germany and Singapore, the company leverages its technologies and expertise to provide efficient and cost-effective biologics solutions.
As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects). The company continues to focus on sustainability as a cornerstone of long-term business growth, driving green technology innovations while maintaining excellence in Environment, Social and Governance (ESG) practices.
