The successful assessment of Drug Substance Facility 2, Drug Product Facility 1, and the Drug Product Packaging Center validates the company’s quality management systems and cross-functional operational standards. This certification strengthens the firm's global footprint, allowing clients to leverage its integrated manufacturing network to meet regulatory requirements in major international markets.
WuXi Biologics Clears Brazil GMP Inspection for Cancer Immunotherapy
Zero findings during a five-day inspection have granted WuXi Biologics official GMP certification from Brazil's ANVISA. The approval covers two Wuxi-based manufacturing facilities and a packaging center, enabling the company to provide end-to-end commercial supply of an anti-PD-L1 monoclonal antibody for cancer treatment within the Latin American market.
CEO Dr. Chris Chen noted that the certification reinforces the company's commitment to compliance and supports the broader goal of expanding patient access to affordable biologics. By the end of 2025, WuXi Biologics had cleared 46 regulatory inspections, including 22 conducted by the FDA and EMA. The organization currently manages 15 GMP-certified facilities and continues to support nearly 1,000 integrated client projects globally.
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