Altruist Biologics’ Suzhou Site Receives EMA GMP Certification
The company’s Quality Risk Management framework enabled proactive identification of compliance risks, reduced uncertainties associated with cross-regional technology transfer, and provided greater predictability as therapies advance toward regulatory submission and commercialization. The post Altruist Biologics’ Suzhou Site Receives EMA GMP Certification appeared first on GEN - Genetic…
Altruist Biologics, a contract development and manufacturing organization based in China, announced that its Suzhou commercial manufacturing site has earned prestigious EMA GMP certification. This is the facility's first achievement of such a certification. The European Medicines Agency (EMA) inspection validated the site's adherence to Good Manufacturing Practice (GMP) standards, which is crucial for marketing authorization of biologics products for a biopharmaceutical client.
The EMA inspection scrutinized the entire biologics manufacturing process, as well as the facility's quality systems and operational efficiency. The company highlighted the success of its Quality Risk Management (QRM) framework, which helps identify compliance risks proactively, mitigate uncertainties in cross-regional technology transfer, and ensure smooth global regulatory submissions and commercialization of innovative therapies.
Kaisong Zhou, chairman and CEO of Altruist Biologics, emphasized that quality is integral throughout the biologics lifecycle, from development to commercialization. The Suzhou site, along with its Hangzhou counterpart, is equipped to meet the stringent GMP requirements of multiple regulatory bodies, including the EMA, FDA, PMDA of Japan, and NMPA of China.
The Suzhou facility boasts 60,000 liters of antibody manufacturing capacity and an ADC clinical manufacturing line, while the Hangzhou site offers a total antibody manufacturing capacity of 172,000 liters, with 80,000 liters currently operational. Ongoing construction of a 2,000-liter antibody production line is slated for completion by mid-2027.
Altruist Biologics, a wholly-owned subsidiary of Innovent Biologics, has garnered multiple recognitions from other global regulatory authorities, including successful completion of remote interactive evaluations by the FDA, and inspections by the NMPA and COFEPRIS of Mexico, as well as over 40 quality audits conducted by global clients.
With additional planned capacity coming online, Altruist's total CDMO manufacturing capacity is projected to reach 232,000 liters.
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