The four-day audit scrutinized the facility’s quality management, data integrity, and technical infrastructure, specifically focusing on biosafety control for cell banks and commercial unprocessed bulk. By validating these processes, the Suzhou site enables a diverse range of modalities, including antibodies, enzymes, and fusion proteins, to satisfy EU marketing authorization requirements.

Dr. Chris Chen, CEO of WuXi Biologics, noted that biosafety testing remains a fundamental lifecycle requirement for biologics, from initial safety validation to final commercial batch release. Beyond the European market, the company’s biosafety operations in Suzhou and Shanghai have secured endorsements from the U.S. FDA, Japan’s PMDA, and Australia’s TGA. To date, the testing centers have supported over 1,700 investigational new drug or biologics license applications, reinforcing the firm’s role as a critical node in the global pharmaceutical supply chain.