On October 19, 2018, CCRM and UHN co-hosted the launch of the Centre for Cell and Vector Production (CCVP), a new 20,000 ft2 Good Manufacturing Practices facility. CCVP is the first facility of its kind in Toronto, and will produce clinical-grade cells and viral vectors for Phase 1 and 2 clinical trials—helping to meet the growing demand from patients seeking cell and gene therapies around the world.
“Today marks a significant milestone for CCRM,” said Dr. Michael May, President and CEO of CCRM of the opening. “As a leader in developing and commercializing regenerative medicine technologies and cell and gene therapies, we are now able to manufacture cell and gene therapy products for patients for years to come. With R&D capabilities in-house and access to industry-leading know-how and technologies through our partnership with GE Healthcare, we will help the industry move closer to delivering on the promise of regenerative medicine as a possible cure for many diseases and conditions.”
CCRM and UHN partnered to design and build the CCVP, which cost an estimated $25 million for construction, equipment and operations. Financial support was provided by the Canada Foundation for Innovation, the Federal Economic Development Agency for Southern Ontario, the Government of Ontario, and other partners, including private donors through the Toronto General & Western Hospital Foundation. CCRM will manage the day-to-day operations of manufacturing cells and viral vectors for early phase clinical trials and already has a pipeline of industry and academic projects in place.
"CCVP will fill a much needed gap for the thriving regenerative medicine industry in Toronto," said Dr. Brad Wouters, Executive Vice President, Science and Research at UHN. "Cell and gene therapy products hold tremendous potential for many diseases with unmet clinical need—from cancer to heart disease—and this new facility will accelerate the development of these transformative health care solutions for patients. With all of the research excellence at UHN, such as that at the McEwen Centre for Regenerative Medicine, and at other local leading institutions, Toronto is now uniquely positioned to become a global leader in this area."
The facility is designed to meet international standards and be compliant with Health Canada, the U.S. FDA, and the European Medicines Agency Good Manufacturing Practices for early-phase materials in the cell and gene therapy markets. Features include skilled personnel, ten Grade B clean rooms, cryogenic storage, an in-house quality control (QC) laboratory, a robust quality management system and specialized cell processing hardware. Services offered include full manufacturing and release of cell and viral vector materials, QC testing, access to clean rooms, cell bank creation, assay development, technology transfer, training services, supplier management and audit support services.
For more information, please visit ccrm.ca