Cell and Gene Therapy Manufacturing
C3i is the only fully operational state-of-the-art validated GMP manufacturing facility in Canada with Commercial Capacity. C3i GMP cell and gene therapy manufacturing services cover the entire process from cell line development, process optimization, analytical testing, scale-up, and fill/finish.
Reach out to learn more about our cell therapy manufacturing services.
GMP Manufacturing
Cell and gene therapy is transforming how we treat disease, offering highly personalized approaches targeting the root causes of illness rather than just the symptoms. These advanced therapies involve modifying cells or genetic material to restore normal function, making them especially promising for previously considered untreatable conditions, such as rare genetic disorders, certain cancers, and autoimmune diseases.
As the field grows, so does the demand for specialized expertise and infrastructure to bring these innovations to market safely and efficiently. This is where cell therapy manufacturing plays a critical role. Manufacturers are essential partners in the journey from bench to bedside, ensuring that complex therapies are produced under strict regulatory standards like GMP (Good Manufacturing Practices). These standards are vital for maintaining product consistency, safety, and efficacy, especially as treatments move from clinical trials to full commercial deployment.
For biotech companies and pharmaceutical innovators, partnering with a reliable manufacturer helps reduce time to market, mitigate regulatory risks, and scale production efficiently. For patients, it means faster access to cutting-edge treatments that dramatically improve their quality of life.
With demand for cell and gene therapy increasing worldwide, manufacturers with the right capabilities, facilities, and regulatory approvals are key to making these therapies’ promises a global reality.
Process Development
C3i is your partner to scale up your cell manufacturing. We fill the gap between your research findings and therapy for patients. Our expertise includes:
- Technical transfer from customer conditions
- Comparability studies
- Bioprocess design based on product specification (Quality by design)
- Bioprocess scale-up & optimization (efficiency, closed system)
- Development of cost-effective strategies
- Process standardization and validation
- Critical parameter definition
- Stability studies
- Transport optimization and qualification
- And other related services
GMP Cell Manufacturing
Diverse Cell Manufacturing
C3i GMP cell manufacturing service can help you achieve your goals with speed, efficiency, and quality. We offer a diverse cell manufacturing expertise in:
- TcR
- CAR-T
- NK
- MSCs
- HSCs
- iPSCs
- Autologous and allogeneic
- And other various cell types and technologies
Cell Modification
C3i has a wide expertise in Cell modification using:
- Viral vectors
- Electroporation systems
- CRISPR editing
- mRNA
GMP Vector Manufacturing
C3i offers GMP viral vector manufacturing, adhering to stringent Good Manufacturing Practices and led by a team of skilled professionals. This offering reflects our dedication to expanding the horizons of medical potential. Our manufactured vectors, applicable to both cell and gene therapies, embody our commitment to driving advancements in healthcare possibilities.
Master Cell Banking
Our cutting-edge GMP facility proudly offers Master Cell Bank (MCB) manufacturing, a crucial component in the production of biotherapeutics. With meticulous attention to detail and adherence to strict quality control, our expert team cultivates, characterizes, and preserves cell lines to establish reliable MCBs.
The Facility
C3i is Canada’s only fully validated GMP center compliant with EMA, and Health Canada regulations with commercial capacity.
We are leaders in GMP cell therapy products and services for local and international companies.
- 37 000 sq ft State-of-the-art facilities
- 14 GMP clean rooms
- EMA & Health Canada Compliant
Your partner in cell therapy manufacturing
Our GMP cell and gene therapy manufacturing services are more than a service. This partnership connects you with the best in the field. By choosing C3i, you are choosing to work with a team of professionals who are committed to your success and will support you throughout your product development journey.