WuXi Biologics' Suzhou Biosafety Testing Center Receives Fourth EMA GMP Certification

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WuXi Biologics' Biosafety Testing Center in Suzhou has received its fourth Good Manufacturing Practice certification from the European Medicines Agency, enabling 19 biologics from 13 clients to pursue European Union marketing authorization. The four-day inspection, which concluded with zero critical findings, covered quality management, facilities, testing methods, standard operating procedures, computerized systems, and personnel. The 19 products span antibodies, enzymes, and fusion proteins, with the majority developed and manufactured on WuXi Biologics' integrated platform. The facility's quality system, infrastructure, technical capabilities, data integrity, and organizational management were highly recognized by the EMA. As of December 2025, the company's biosafety testing centers in Suzhou and Shanghai have supported over 1,700 investigational new drug or biologics license applications.

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WuXi Biologics' Suzhou biosafety testing center received its fourth EMA GMP certification, enabling 19 biologics from 13 clients to pursue EU marketing authorization.

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