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A new 20,000-square foot facility has been opened by UHN and the Centre for Commercialization of Regenerative Medicine (CCRM) to produce clinical-grade cells and viral vectors for Phase 1 and 2 clinical trials – helping meet growing demand from patients around the world seeking cell and gene therapies.
The Centre for Cell and Vector Production (CCVP), which cost an estimated $25 million for construction, equipment and operations, is located in the MaRS Discovery District in downtown Toronto.
CCRM and UHN partnered to design and build the facility, officially opened at a news conference Friday at MaRS. 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," 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 healthcare solutions for patients."
Dr. Wouters added that with all of the research excellence at UHN, such as 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."
Dr. Michael May, President and CEO of CCRM, called the opening "a significant milestone" for his organization, which is a funded by the Federal and Ontario governments, and leading academic and industry partners.
"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," Dr. May said.
"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."
Chris Taylor, a stem cell transplant recipient and UHN Patient Partner, told the audience about his 18-year journey since finding out he had Stage IV non-Hodgkin's lymphoma, a treatable but not curable blood cancer.
"This is thrilling to me as I know how important these clinical trials are now and will be in the future with new cell therapies approved all the time," Chris said. "From my perspective, these cell and gene therapies are a gift of hope to those of us living with, or being treated now for cancer or other types of intractable diseases such as heart disease, arthritis, diabetes, stroke and spinal cord injuries to name a few."
Dr. Chris Paige, Senior Scientist at UHN, talked about "how thrilled I am to see this day – for lots of reasons – all linked by the power of cooperation.
"This project has brought together expertise from so many different disciplines – government, private and public companies, hospitals, researchers and patient care experts striving to create those advances that will solve the unment clinical needs of our patients."
The CCVP, known as a Good Manufacturing Practices 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, 10 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.
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.
Read more information about CCRM.