Regulatory compliant Good Manufacturing Practices (cGMP) facility producing cell and gene therapies to support Phase I/II in-human clinical trials
Operated by CCRM, the Centre for Cell and Vector Production (CCVP) is a world-class GMP facility built in partnership with University Health Network (UHN), located at MaRS in downtown Toronto, adjacent to some of Canada’s leading hospitals and research institutes.
CCVP has robust and Phase I/II quality systems, cutting-edge technologies and a large team supporting US/EU/Canada regulatory submissions for cell and gene therapies. CCVP opened its doors in 2018 and has been working with industry and academics to meet their needs. CCRM was launched in Toronto’s Discovery District on June 14, 2011.
CCVP includes:
- 10 suites, eight for cell therapies and two for viral vectors, in 20,000 ft2 facility
- ISO Class 7/Grade B clean rooms for Phase I and II clinical trial material manufacturing and testing
- Designed for USFDA, Health Canada, EMA compliance, including >10 client audits, including EU QP
- Located a short distance from Toronto Pearson International Airport
MANUFACTURING SERVICES
- Cell Manufacturing
- Viral Vector Manufacturing
- Caesium-137 Gamma Irradiation
- Cell Banking
- Fill and Finish
- Cryopreservation
MANUFACTURING SUPPORT
- On-site QC Testing Capabilities
- On-site QA/Audit Support
- Expert Regulatory Guidance
- Cryogenic Distribution using Validated Logistics
- Extensive Process Development Capabilities and Manufacturing Science and Technology group
QUALITY SYSTEMS - Robust and phase-appropriate:
- Compliant with U.S. and Canadian cGMPs, as well as EU ATMP Guidelines
- Supports CTA/IND acceptance by global regulators, minimizes variability, accelerates timelines, reduces costs
- Independent quality department including QC and QAR
- Robust document management, change control and CAPA systems
CUTTING-EDGE TECHNOLOGIES - CCVP equipment capabilities include:
- Hardware (USP/DSP): Cytiva, Miltenyi, Eppendorf, Sartorius and more
- QC capacity: real-time PCR, multi-mode plate reader, Endosafe, flow cytometry
- Software: MasterControl® QMS, POMS® electronic batch record and material management systems
- Cryo-storage for 25,000+ vials
- Crystel M1 semi-automated fill-finish for vials
- Gamma cell irradiator
EXPERIENCE and EXPERTISE - 50+ staff with significant experience in cell and gene therapy manufacturing:
- Supporting active US IND clinical trials, treating patients
- Manufacturing for global clinical trials
- Small-scale autologous and large-scale (200 L) allogeneic batches as well as scalable workflows
- Complex and highly customized manufacturing runs (CAR-T, PSC, NK, MSC, LVV, AAV)
- Chemical industries
- Healthcare and social services
- Life sciences, pharmaceuticals and medical equipment
- Manufacturing and processing
Specialized labs and equipment
| Specialized lab | Equipment | Function |
|---|---|---|
| CCVP | Miltenyi CliniMACs Plus | Automated cell separation, cell enrichment and cell depletion system |
| CCVP | Cytiva Sepax C-Pro Cell Processing System | Closed and automated cell processing system |
| CCVP | Best Theratronics GammaCell 1000 Irradiator | Blood irradiation |
| CCVP | Thermo Scientific CO2 Incubators | Clean room compatible large capacity incubators for culture growth |
| CCVP | NuAire NU-5400-600 Biosafety Cabinet | Biological safety cabinets that provide personnel, product and environmental protection |
| QC Testing Lab | Beckman Coulter MoFlo Gallios Flow Cytometer | Detect and measure the physical and chemical characteristics of a population of cells |
| CCVP | Brooks Cryo storage system (232292/232297) | Automated cryo storage system for cellular products |
| CCVP | Sorvall WX90 Ultracentrifuge | Cell separation |
| QC Testing Lab | Agilent AriaMx Real Time PCR System | Integrated qPCR solution for amplification, detection and data analysis |
| CCVP | Thermo Scientific CryoMed Controlled Rate Freezer, Model 7452 Series | Programmable controlled-rate freezer for safe sample freezing |
Private and public sector research partners
- University Health Network (UHN)
- Centre for Commercialization of Regenerative Medicine (CCRM)
- University of Toronto