Suzhou, ChinaJune 18, 2026 /PRNewswire/ — WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that its Biologics Safety Testing Center in Suzhou (hereinafter referred to as “WuXi Biologics Testing”) has successfully passed the European Medicines Agency (EMA) GMP inspection with zero major findings for the fourth time.
This inspection covered 19 EU marketing authorization application products from 13 WuXi Biologics clients, including antibodies, enzyme preparations, and fusion protein therapeutics, most of which were developed and manufactured through WuXi Biologics’ integrated platform. The EMA inspection focused on the quality and safety testing of cell banks and commercial cell harvest fluids for these products.
GMP-compliant quality and safety testing of commercial cell harvest fluids is a critical component of pre-marketing inspections for biologics seeking EU approval, as well as a routine inspection item by international regulatory agencies for marketed products. Over the four-day comprehensive inspection, covering quality management, facilities and equipment, testing methods, standard operating procedures, computerized systems, and personnel management, WuXi Biologics Testing’s Suzhou site received high recognition from the EMA for its quality system, hardware capabilities, technical expertise, data integrity, and organizational management.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “From pre-validation safety testing at the cell bank and harvest fluid stages to final quality assurance at the batch release of marketed products, biologics safety testing runs through key nodes of the entire biologics lifecycle, ensuring that products meet stringent regulatory requirements from development to commercialization. We remain committed to a high-quality system aligned with international GMP standards as our foundation, consistently providing robust safeguards for product quality. This not only reflects the consistent capabilities of WuXi Biologics’ global network but also the results of our long-term adherence to high-standard practices, underscoring our firm commitment to empowering clients and benefiting patients worldwide.”
WuXi Biologics Testing operates two sites in Suzhou and Shanghai, offering services including comprehensive cell bank characterization for CHO, HEK293, and E.coli, diverse biologics safety testing, GMP-compliant batch release testing for marketed biologics, and virus clearance studies based on its proprietary high-quality virus production platform in accordance with Good Laboratory Practice (GLP). As of December 2025, WuXi Biologics Testing has supported global clients in successfully submitting over 1,700 IND or BLA applications, with its quality system and technical capabilities highly recognized by global regulatory agencies and clients.
In addition to the EMA, WuXi Biologics Testing has previously passed remote interactive evaluations by the U.S. Food and Drug Administration (FDA) and received certifications from the China National Accreditation Service for Conformity Assessment (CNAS), China’s National Medical Products Administration (NMPA), Health Canada (HC), Australia’s Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), as well as over 510 quality audits from global clients.
About WuXi Biologics
WuXi Biologics (Stock Code: 2269.HK) is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO). Through its open-access, integrated biologics capabilities and technology platforms, the company provides comprehensive end-to-end services to help partners discover, develop, and manufacture biologics, from concept to commercial production, accelerating global biologics R&D, reducing costs, and benefiting patients worldwide*.
Leveraging its global network connecting China, the U.S., Ireland, Germany, and Singapore, WuXi Biologics employs over 13,000 professionals, including industry experts and scientists in biologics R&D and manufacturing, technological innovation, and operational excellence. With its leading technology platforms and deep expertise, the company offers efficient, cost-effective, and scalable biologics solutions tailored to client needs at different stages. Additionally, WuXi Biologics systematically integrates digital capabilities and infrastructure into the full value chain of biologics R&D, lab operations, and manufacturing, transforming data, computing, and predictive capabilities into more transparent client collaboration, faster R&D timelines, smarter operational management, and more efficient production delivery. As of the end of April 2026, WuXi Biologics supported a comprehensive project portfolio of 982 projects, including 78 Phase III and 25 commercial manufacturing projects, with complex molecule projects accounting for over 50% of the total project count.
WuXi Biologics views sustainable development as the cornerstone of long-term business growth. The company continuously promotes green innovation technologies, providing global partners with advanced end-to-end green CRDMO solutions while achieving outstanding ESG performance. Upholding the principle of creating shared value, WuXi Biologics collaborates with stakeholders to build a sustainable ecosystem, driving both social value and ecological benefits through responsible operational models, enabling synergistic empowerment across the full value chain.
For more information, please visit: www.wuxibiologics.com
*Awarded “2026 Biologics CDMO Leadership Award” (Large CDMO Category) (Life Science Connect / Outsourced Pharma)
*Awarded “2026 Best Contract Development and Manufacturing Organization Award” (ABEA)
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