Altruist Biologics’ Suzhou manufacturing site received EMA GMP certification with zero critical findings, the company said. The certification supports an EU marketing authorization application for a biologics product from a biopharmaceutical customer, following an EMA inspection covering the full biologics manufacturing lifecycle. Altruist said the inspection assessed quality systems, data integrity controls, and operational performance. It also highlighted its quality risk management framework designed to identify compliance risks and improve predictability during technology transfer across regions. The site is described as having antibody manufacturing capacity and an ADC clinical manufacturing line, positioning the CDMO for scaling biologics and antibody-drug conjugate output in support of global regulatory submissions.