Pharma Focus America

C3i Center Inc. Becomes the First CDMO in Canada to Receive Approval for Commercial Production of Cell Therapy Drugs

Friday, June 21, 2024

C3i Center Inc (C3i) has received regulatory approval from Health Canada in the form of a Drug Establishment License (DEL), making it the first Contract Development and Manufacturing Organization (CDMO) in Canada authorized to commercially produce cell therapies.

This approval was granted after a detailed inspection by Health Canada's cell and gene therapy experts. The DEL certification acknowledges C3i's top-tier expertise, regulatory knowledge, and high-quality standards.

C3i, stated, "Our team has worked diligently to meet the DEL requirements, and we are proud to have earned Health Canada's approval for commercial cell therapy manufacturing. As the first CDMO in Canada to achieve this milestone, we are excited for future developments. We aim to manufacture cell and gene therapies for the global market, with the European Medicines Agency (EMA) expected to conduct an inspection later this fall."

C3i assists clients in process development, scale-up, and manufacturing for phase 1 to phase 3 clinical trials, as well as commercial production of cell and gene-modified cell therapies. The company is also expanding its services to include the production of viral vectors, exosomes, and other autologous and allogeneic cellular therapies.



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