Located in Toronto's Discovery District, CCRM is in the heart of Canada’s premier health care innovation hub, and is surrounded by over 30 world-class clinical and research institutions. With access to more than 140,000 students and scientists in Toronto, CCRM is deeply interconnected in a thriving biomedical cluster.
Our 40,000 ft² (~4,000 m²) home in the MaRS Centre houses on-site consultation offices, a large and fully-equipped containment level 2 (CL2) laboratory, and a stand-alone 20,000 ft² (~1,300 m²) Good Manufacturing Practices (GMP) facility, to be operational in 2019.
Process Development Suite:
At 10,000 ft² (~930 m²), our laboratory is based on a modular design that includes a large, fully-flexible process hall enabling us to mimic advanced biologics manufacturing workflows and practices. This process hall is central to the capabilities of the Centre for Advanced Therapeutic Cell Technologies (CATCT) — an advanced manufacturing centre of excellence focused on addressing the many challenges associated with cell and gene therapy manufacturing. The CATCT is jointly supported by GE Healthcare and the Federal Economic Development Agency for Southern Ontario (FedDev Ontario).
GMP Facility (Operational in 2018):
CCRM and the University Health Network (UHN) have partnered to design and build the Centre for Cell and Vector Production (CCVP). This facility is designed to be compliant with Health Canada, United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) GMPs for early-phase materials in the cell and gene therapy markets. Specifically, the production of materials to support Phase I and Phase II in human clinical trials. Our GMP facility will assist with the transfer to clients’ manufacturing facilities or to a contract manufacturing organization (CMO).
CCVP features 10 class B clean rooms, cryogenic storage, a cell irradiator, an in-house quality control (QC) laboratory, a robust quality management system, and specialized cell processing hardware. Services offered in CCVP include full manufacturing and release of cell and viral vector materials, QC testing, access to clean rooms, cell bank creation, training services, supplier management and audit support services.
The CCVP GMP facility will be operational in October 2018.
Designed to be Health Canada, USFDA and EMA compliant
Positive and negative pressure clean rooms, for cell and viral production, respectively
Facilities for QC and quality assurance (QA) activities
Two vector production suites totalling 258 ft² (~24 m²)
Eight clean room suites: five at 236 ft² (~22 m²) and three at 301 ft² (~28 m²)
CCRM's state of-the-art facility is located in downtown Toronto within the MaRS Discovery District.
CCRM has received ISO 9001:2015 certification for its quality management system. ISO 9001 is a standard that sets out the quality management system’s requirements to help ensure that products and services consistently meet customers’ requirements, and that quality is consistently improved.