C3i Becomes First Canadian CDMO with Cell Therapy License

• C3i Center Inc. receives Drug Establishment License (DEL) from Health Canada.

• C3i is the first CDMO in Canada to gain this approval for cell therapies.

C3i Center Inc. has achieved a significant milestone by obtaining a Drug Establishment License (DEL) from Health Canada, authorizing the commercial production of cell therapies. This approval makes C3i the first CDMO in Canada to reach this achievement.

Following an inspection by Health Canada’s cell and gene therapy experts, the DEL approval underscores C3i’s expertise, regulatory compliance, and high-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,” said Louisa Petropoulos, CEO of C3i.

C3i specializes in process development, scale-up, and manufacturing for phase 1 to phase 3 clinical trials, and commercial cell and gene-modified cell therapies. The company is expanding its capabilities to include viral vectors, exosomes, and other autologous and allogeneic cellular therapies. “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,” Petropoulos added.