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 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

  • University Health Network (UHN)
  • Centre for Commercialization of Regenerative Medicine (CCRM)
  • University of Toronto

Title

URL

CCRM

http://www.ccrm.ca 

The Centre for Cell and Vector Production: A look inside 

https://www.ccrm.ca/regenerative-medicine-videos/the-centre-for-cell-and-vector-production-a-look-inside/

CCRM Annual Report 2018 (pages 2-5, inclusive)

https://www.ccrm.ca/wp-content/uploads/2012/02/CCRM-2018-Annual-Report.pdf

The Centre for Cell and Vector Production brochure

https://www.ccrm.ca/wp-content/uploads/2017/02/CCVP-Flyer-Final.pdf

Introducing the Centre for Cell and Vector Production 

https://www.ccrm.ca/regenerative-medicine-videos/introducing-the-centre-for-cell-and-vector-production/

How Canada can become a leader in regenerative medicine 

https://www.innovatingcanada.ca/technology/canada-can-become-leader-in-regenerative-medicine/?utm_source=client&utm_medium=social#

Ontario continues to establish its role as a world leader in regenerative medicine 

https://www.ctontario.ca/ontario-continues-to-establish-its-role-as-a-world-leader-in-regenerative-medicine/

CCRM and the new CCVP Facility: an interview with Director of Operations, Helen Pejnovich 

https://ospe.on.ca/community/ccrm-new-ccvp-facility/

Supporting the development of regenerative medicines 

https://www.technologynetworks.com/biopharma/blog/supporting-the-development-of-regenerative-medicines-305905