- Altruist Biologics said its Suzhou commercial manufacturing facility has passed an EMA GMP inspection with zero critical findings, marking the facility’s first EMA GMP certification.
- The inspection supported an EU marketing authorization application for a biologics product from a biopharmaceutical client and assessed the facility’s manufacturing lifecycle, quality systems and operational performance.
Altruist Biologics said its Suzhou commercial manufacturing facility has successfully passed a Good Manufacturing Practice (GMP) inspection by the European Medicines Agency (EMA) with zero critical findings. The company said this is the first time the facility has received EMA GMP certification.
The inspection supported a European Union marketing authorization application for a biologics product from a biopharmaceutical client. According to Altruist, the EMA conducted a comprehensive assessment covering the full biologics manufacturing lifecycle, including the facility’s quality systems and operational performance. The inspection reviewed quality management, infrastructure, technical capabilities, data integrity controls and organizational management.
Altruist said its Quality Risk Management (QRM) framework is designed to identify compliance risks proactively and reduce uncertainties associated with cross-regional technology transfer. The company said this approach is intended to provide greater predictability as therapies progress toward regulatory submission and commercialization. Dr. Kaisong Zhou, Chairman and CEO of Altruist Biologics, said: “Quality spans the entire biologics lifecycle, ensuring compliance with rigorous regulatory requirements from development through commercialization.”
The Suzhou facility has 60,000 liters of antibody manufacturing capacity and an ADC clinical manufacturing line, providing services for antibodies, fusion proteins and antibody-drug conjugates. Altruist said its Suzhou and Hangzhou sites are designed and operated to meet GMP requirements across the EMA, U.S. Food and Drug Administration, Japan’s PMDA and China’s NMPA. The Hangzhou site has 80,000 liters of operational antibody manufacturing capacity across four 20,000-liter stainless steel bioreactors, with a 2,000-liter production line under construction that is expected to be operational by mid-2027.
Altruist said it currently has 140,000 liters of operational CDMO manufacturing capacity and expects total capacity to reach 232,000 liters as planned capacity comes online. The Suzhou site has also completed a remote interactive evaluation by the FDA and passed inspections by the NMPA and Mexico’s COFEPRIS, in addition to more than 40 quality audits conducted by global clients.
