C3i Center Inc. has received regulatory approval in the form of a Drug Establishment License (DEL) to commercially produce cell therapies, making it 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,” said 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.
![GMP mRNA](https://static.packgene.com/wp-content/uploads/2023/07/13.jpg)
Check out our AAV CDMO service to expedite your gene therapy research
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
New Era of Genome Engineering: Beyond CRISPR
“Everything in the last 14 years of genome editing has been based on CRISPR. We have been whipping this horse for a decade and a half, but we need more programmable functions with complexity beyond the molecular scissors that cut RNA and DNA,” says Patrick Hsu, PhD,...
When the Wegovy stops, the weight gain restarts. Could a GLP-1 gene therapy change that?
GLP-1 drugs like Eli Lilly's Zepbound and Novo Nordisk's Wegovy work to address obesity—as long as a patient keeps taking them. Harith Rajagopalan, M.D., Ph.D. thinks his company, Fractyl Health, may have the answer: a gene therapy that integrates a GLP-1-secreting...
REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients
Company to begin enrollment of patients aged 1-3 years Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal program design Based on recent commercial...
Top 10 Companies Dominating the Global Drug Delivery Systems Market
"Revolutionizing Healthcare Horizons: Delving Deep into Advanced Drug Delivery Systems (ADDS) and Forecasting an Explosive $359.1 Billion Market Growth by 2028, BCC Research Study" Demand for effective solutions has never been so urgent to prevent global chronic...
Related Services
![](https://static.packgene.com/wp-content/uploads/2023/01/9-1.png)
Plasmids GMP Services
![](https://static.packgene.com/wp-content/uploads/2023/01/10-2.png)
AAV GMP Services
![aav icon](https://static.packgene.com/wp-content/uploads/2023/01/9-1.png)