C3i Center Inc is the First CDMO in Canada to Receive Approval for a Drug Establishment License to Commercially Produce Cell Therapy Drug Products.

We are very proud to announce that we have received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies. This makes us the first CDMO in Canada to achieve this milestone. 

The approval follows an inspection by the cell and gene therapy experts from Health Canada. The DEL approval recognizes C3i as having industry-leading expertise, regulatory know-how, and strong quality standards. 

“The C3i team worked hard to meet the requirements of a DEL and are proud that we received approval from Health Canada to commercially manufacture cell therapies.”

– Louisa Petropoulos, CEO of C3i.

“We are excited to be the first CDMO in Canada to reach this milestone, and there is more to come. Our goal is to manufacture cell and gene therapies for the global market. We expect to have the European Medicines Agency (EMA) conduct their inspection later this fall.”

C3i supports its clients in process development, scale-up and manufacturing for phase 1 to phase 3 clinical trials, as well as commercial cell and gene-modified cell therapies. C3i continues to expand its capabilities to include the production of viral vectors, exosomes, and other autologous and allogeneic cellular therapies.

For more details, read the full press release here.