WuXi Biologics has achieved a significant milestone by obtaining its fourth Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA) for its Suzhou Biosafety Testing Center, with no critical findings reported during the inspection.
This recent certification underscores the facility's importance as a global quality center for biologics testing, facilitating European Union marketing authorizations for 19 biologic products from 13 clients. The products in question include a range of biologics such as antibodies, enzymes, and fusion proteins, primarily developed on WuXi's integrated platform.
The EMA's inspection assessed various aspects of biosafety quality control, including the testing of cell banks and raw materials. Inspectors spent four days reviewing the center's quality management systems, equipment, testing methodologies, and personnel capabilities, ultimately recognizing the site's robust quality systems and organizational management.
As biosafety testing is essential for regulatory compliance in the European market, this certification further enhances WuXi Biologics’ role in the global biologics landscape. Chris Chen, CEO of WuXi Biologics, emphasized the importance of maintaining high-quality standards throughout the lifecycle of biologics, ensuring that they meet stringent regulatory requirements from development to commercialization. This achievement not only strengthens WuXi's capabilities but also positions it as a vital partner in advancing global biologics development.