Pharma Focus America

C3i Centre Becomes Canada's First CDMO to Secure License for Commercial Cell Therapy Manufacturing

Monday, June 24, 2024

C3i Centre (C3i) has announced that it has secured a Drug Manufacturing License (DEL) for the commercial production of cell therapy, becoming the first CDMO in Canada to achieve this feat.

This milestone comes after a thorough inspection by Health Canada's cell and gene therapy specialists. The DEL approval highlights C3i's exceptional expertise, regulatory knowledge, and high-quality standards.

"The C3i team worked tirelessly to meet the DEL requirements and is honored to receive approval from Health Canada for the commercial manufacturing of cell therapies. We are thrilled to be the first Canadian CDMO to reach this milestone," stated Louisa Petropoulos, CEO of C3i. "Our objective is to produce cell and gene therapy drugs for the global market. We also anticipate an inspection by the European Medicines Agency (EMA) later this fall."

C3i assists clients in process development, scale-up, manufacturing, and commercialization stages of cell and genetically modified cell therapies from Phase I to Phase III clinical trials. The company is continuously enhancing its capabilities to include the production of viral vectors, exosomes, and various autologous and allogeneic cell therapies.

 

Source: businesswire.com

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