Altruist Biologics, a CDMO based in China, reports that its Suzhou commercial manufacturing facility has successfully passed a GMP inspection by the European Medicines Agency (EMA) with zero critical findings. This marks the first time the facility has successfully received EMA GMP certification.
The inspection supported the European Union marketing authorization application for a biologics product from a biopharmaceutical client. The EMA inspection involved an assessment covering the full biologics manufacturing lifecycle and a review of the facility’s quality systems and operational performance.
The Suzhou facility’s quality management system, infrastructure, technical capabilities, data integrity controls and organizational management were recognized by the EMA, according to the company. The company’s Quality Risk Management (QRM) framework has enabled proactive identification of compliance risks, reduced uncertainties associated with cross-regional technology transfer, and provided greater predictability as innovative therapies advance toward global regulatory submission and commercialization, stated Kaisong Zhou, PhD, chairman and CEO of Altruist Biologics.
“Quality spans the entire biologics lifecycle, ensuring compliance with rigorous regulatory requirements from development through commercialization,” he said. “The recent EMA GMP certification exemplifies that our robust manufacturing processes, quality systems, talent and world-class facility meet regulatory requirements, and we have the agency’s trust to manufacture and deliver products on behalf of our global partners and the patients they serve.”
Altruist’s Suzhou and Hangzhou sites are designed and operated to meet GMP requirements across multiple regulatory authorities, including the EMA, FDA, the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and the National Medical Products Administration (NMPA) of China, pointed out Zhou.
Equipped with 60,000 liters of antibody manufacturing capacity and an ADC clinical manufacturing line, the Suzhou facility provides end-to-end services for antibodies, fusion proteins and antibody-drug conjugates, he continued. The Hangzhou site is designed with a total antibody manufacturing capacity of 172,000 liters, with 80,000 liters currently operational across four 20,000-liter stainless steel bioreactors. A 2,000-liter antibody production line is currently under construction and is expected to be operational by mid-2027.
Altruist collectively has 140,000 liters of operational CDMO manufacturing capacity, representing approximately 20% of China’s total capacity, explained Zhou. As additional planned capacity comes online, Altruist’s total manufacturing capacity is expected to reach 232,000 liters.
In addition to the EMA, the Suzhou site has received multiple recognitions from other global regulatory authorities, said Zhou. It has successfully completed remote interactive evaluation by the FDA, and has passed inspections by the NMPA and the Federal Committee for Protection from Sanitary Risks (COFEPRIS) of Mexico, as well as more than 40 quality audits conducted by global clients.
Altruist Biologics, which will be exhibiting at booth 1027 at BPI, is a wholly-owned subsidiary of Innovent Biologics.