The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of GMP (Good Manufacturing Practice) compliance, enabling it to make innovative medicines available to European patients.
Last year, C3i became the first CDMO for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
“As a Canadian CDMO, we’re proud to offer innovative solutions to the challenges of biomanufacturing and commercializing treatments that change lives,” said Yvan Côté, CEO. “Our team adheres to strict quality and safety standards, which are crucial in our industry. Obtaining approvals from Health Canada and the EMA reaffirms our dedication to patient safety and the quality of therapeutic products. This level of certification makes C3i Center a Canadian reference in the field of cell therapy.”
In-house services include quality control testing appropriate to the development phase, biomarker discovery, immune monitoring, and specialized diagnostic testing using its College of American Pathologists accredited laboratories, added Côté.
