Company awarded commercial Drug Establishment License (DEL) for Canada following successful inspection of C3i’s contract development and manufacturing organization (CDMO) facility.
MONTREAL--BUSINESS WIRE--
C3i Center Inc (C3i) announced it has received regulatory approval, in the form of a Drug Establishment License (DEL), to commercially produce cell therapies, making C3i 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.
About C3i Center Inc
C3i is a full-service, in-house CDMO with a vision to make life-saving cell and gene therapies available to everyone who needs them. C3i provides services to biotechnology companies, academic research groups, and pharmaceutical companies, supporting the advancement and commercialization of innovative technologies. C3i’s dedicated team is focused on providing clients with tailored services to meet their specific needs, expediting their innovative pipeline from development to commercial. C3i prides itself on delivering on-time, cost-efficient quality results. In-house services include phase-appropriate quality control testing, biomarker discovery, immune monitoring and diagnostic testing with College of American Pathologists (CAP)-accredited laboratories.
To learn more about who we are, visit www.c3icenter.com and for business inquiries, please contact our VP of Business Development, Sandra Donaldson, at [email protected].
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