Centre for Cell and Vector Production (CCVP)

University Health Network, Toronto, Ontario
What the facility does

Regulatory compliant Good Manufacturing Practices (cGMP) facility producing cell and gene therapies to support Phase I/II in-human clinical trials

Areas of expertise

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.

Research services

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)
Sectors of application
  • Chemical industries
  • Healthcare and social services
  • Life sciences, pharmaceuticals and medical equipment
  • Manufacturing and processing
Specialized labEquipmentFunction
CCVPMiltenyi CliniMACs PlusAutomated cell separation, cell enrichment and cell depletion system
CCVPCytiva Sepax C-Pro Cell Processing SystemClosed and automated cell processing system
CCVPBest Theratronics GammaCell 1000 IrradiatorBlood irradiation
CCVPThermo Scientific CO2 IncubatorsClean room compatible large capacity incubators for culture growth
CCVPNuAire NU-5400-600 Biosafety CabinetBiological safety cabinets that provide personnel, product and environmental protection
QC Testing LabBeckman Coulter MoFlo Gallios Flow CytometerDetect and measure the physical and chemical characteristics of a population of cells
CCVPBrooks Cryo storage system (232292/232297)Automated cryo storage system for cellular products
CCVPSorvall WX90 UltracentrifugeCell separation
QC Testing LabAgilent AriaMx Real Time PCR SystemIntegrated qPCR solution for amplification, detection and data analysis
CCVPThermo Scientific CryoMed Controlled Rate Freezer, Model 7452 SeriesProgrammable controlled-rate freezer for safe sample freezing
  • University Health Network (UHN)
  • Centre for Commercialization of Regenerative Medicine (CCRM)
  • University of Toronto