Ontario continues to establish its role as a world-leader in regenerative medicine
Ontario’s reputation as a world-leading centre of activity in stem cell research is growing even stronger.
One of the province’s new assets is the state-of-the-art Centre for Cell and Vector Production (CCVP). Designed and built by the University Health Network (UHN) and CCRM, the centre complies with Canadian, U.S. and European manufacturing regulations and is open for business. “Ontario is a great place to conduct clinical trials, and this centre adds enormously to what we can offer global companies,” says Susan Marlin, CEO of Clinical Trials Ontario (CTO).
Bolstering the excitement surrounding the CCVP is news that in August, BlueRock Therapeutics, a cell and gene therapy company established by scientists at Toronto’s UHN, was purchased by Bayer for an implied total company value of U.S. $1 billion; and a new Advanced Manufacturing Supercluster investment was announced, which will accelerate manufacturing of cell and gene therapies in Canada.
“The whole area of cell therapy is on fire right now,” says Dr. Bradly Wouters, Executive Vice President of Science and Research at UHN and a member of the CTO Board of Directors. “There’s been a lot of research on stem cells and creating them, and we’re now at a point where we’re ready to actually make the cells and test their potential clinically, in patients.”
Inside Ontario’s world-class GMP facility
The 20,000-square-foot CCVP, located at MaRS Discovery District in downtown Toronto, is a world-class good manufacturing practices (GMP) facility that will produce clinical-grade cells and viral vectors for Phase 1 and 2 clinical trials. One cell type manufactured in CCVP is called induced pluripotent stem (IPS) cell, and it can come from adult or embryonic tissue. These cells will be reprogrammed and engineered to give rise to other cell types such as neurons, heart, pancreatic, blood and liver cells, and potentially change the course of disease. Vectors are viruses used by scientists to deliver genetic material into cells during the engineering process.
“This work needs to be done under very rigid and strict control and compliance regulations to ensure that the cells are going to be safe, uncontaminated, to go back into patients,” says Dr. Wouters. “The opportunity here is for our academic partners to develop their own therapies and also to encourage start-ups, biotech and pharma to come here. This represents a new category of future medicine.”
The CCVP features 10 clean room suites, two of which are dedicated to viral vectors, as well as cryogenic storage, a cell irradiator, an in-house quality control (QC) laboratory, a robust quality management system, and specialized cell processing hardware.
CCRM, which will manage the day-to-day operations of CCVP, has a pipeline of industry and academic projects in place. “This is a significant milestone for CCRM,” says Dr. Michael May, President and CEO of CCRM. “As a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies, we are now able to manufacture cell and gene therapy products for patients.”
Watch a video about the new CCVP:
Building a world-class LVV manufacturing platform
Next Generation Manufacturing Canada announced in August its conditional support for a consortium led by iVexSol Canada to develop an advanced manufacturing process for lentiviral vectors (LVVs) – gene-editing reagents that are critical in the manufacturing processes of cell and gene therapies. The project will enable the development of an advanced LVV manufacturing platform in Canada – a first of its kind.
iVexSol (intelligent Vector Solutions) Canada is a newly formed vector manufacturing company founded on an advanced technology that transforms the way LVVs are produced. CCRM, along with GE Healthcare and STEMCELL Technologies, will be core partners in developing the new manufacturing platform, which aims to establish Canada as a world-leader in gene-editing tools and technology.
Connecting to Ontario trial sites and conducting efficient trials
Ontario supports biopharma companies and start-ups in conducting efficient, effective high-quality clinical trials. Through the creation of Clinical Trials Ontario in 2012, a suite of free programs enables industry sponsors to connect directly with trial sites and KOLs, launch studies in less than 90 days and add rescue sites in less than two weeks. Learn more about streamlining clinical trials in Ontario.