C3i Center Inc. specializes in providing comprehensive contract development and manufacturing organization (CDMO) services focused on cell and gene therapy (CGT). The company operates as a fully integrated facility that supports the entire development chain, from process development to commercial manufacturing. C3i is notable for being the only fully validated cGMP center in Canada, compliant with FDA, EMA, and Health Canada regulations, which allows it to manufacture advanced cell and gene products that meet global regulatory standards. Their services encompass a wide range of activities, including laboratory services for assay development, clinical research support, and regulatory affairs, ensuring that clients can navigate the complexities of bringing innovative therapies to market.

In addition to manufacturing, C3i offers extensive clinical research services tailored to cell and gene therapy trials. Their expertise includes regulatory document review, clinical monitoring, pharmacovigilance, and data management, all critical for maintaining the integrity and safety of clinical trials. C3i's commitment to patient-centric solutions is evident in their collaborative approach, working closely with clients to ensure that the therapies developed are not only effective but also compliant with regulatory requirements. This dedication positions C3i as a key player in advancing the field of cell and gene therapy, ultimately aiming to improve patient outcomes through innovative treatment options.

Canada

C3i is a one-stop shop in the development chain of cell & gene therapy. 
With a proven track record of 99% manufacturing success rate across over 300 clinical products, we offer in-house, turnkey services to ensure a streamlined process, eliminating the need to transfer your technology between multiple sites. With over 15 years of expertise in diverse cell manufacturing, we deliver cost-effective solutions ensuring a seamless and successful journey from process development to commercialization.

C3i Center Inc

Company Details