All images by CCRM.
Regenerative medicine is a research area that has gotten plenty of attention around the world lately. One recently launched facility at the forefront of this field is the Centre for Advanced Therapeutic Cell Technologies (CATCT), a collaboration between the Centre for Commercialization of Regenerative Medicine (CCRM) and GE Healthcare.
CATCT, housed in CCRM’s facility in the MaRS Discovery District, an urban innovation hub in Toronto, Ontario, Canada, “is focused on developing advanced manufacturing solutions that address the challenges in cell and gene therapies—or CGT—production, most notably identifying, developing, and adopting optimized and costefficient solutions to manufacture the vast numbers of cells required for clinical trials and commercial production,” says Michael May, PhD, president and CEO of CCRM.
He adds the new center at CCRM has been growing steadily since its creation in 2016, and now has 35 employees out of the total of nearly 80 staff at CCRM. In terms of physical size, CATCT has a fully equipped Level 2 containment lab that takes up around 10,000 square feet of CCRM’s total 40,000 square feet of space.
Aaron Dulgar-Tulloch, PhD, director of CATCT for GE Healthcare Cell Therapy, explains how CATCT’s creation with both industry and government support is part of what makes the center unique. He adds that “GE Healthcare committing $20 million and Canada’s Federal Economic Development Agency for Southern Ontario matching that amount demonstrate the strong need for the solutions that CATCT is providing.”
“The scientists and engineers at CATCT are working hand in hand with cell therapy companies to identify and overcome manufacturing roadblocks and accelerate the development of these innovative therapies,” he says. “CATCT is already providing CGT companies with solutions for manufacturing processes to produce the significant numbers of cells required for clinical and commercial use.”
CATCT’s suite of cutting-edge equipment is another aspect that sets the center apart. That includes instruments for cell processing and analytics, such as the GE Sefia and Sepax C-Pro, in-line sensors, tangential flow and acoustic filtration systems, advanced automated liquid-handling and tissue culture robots, powerful mass spectrometry capabilities, and polychromatic flow cytometers, Dulgar-Tulloch explains.
“As well, we have one of North America’s largest installations of DASbox reactors—24 at 200 milliliters— and an ambr15 system for robust design of experiment development,” he says. “Finally, there are multiple rocking-motion and stirred-tank bioreactors at various configurations, with the capability to operate at culture volumes up to 50 liters.”
As far as current projects go, Dulgar-Tulloch says CATCT has gotten up and running quickly, with multiple projects on the go and already delivering results. Recently, the center reached key milestones in the areas of pluripotent stem cell, immunotherapy, and lentiviral vector (LVV) development programs, he adds.
“Notably, the team was able to produce over 37 billion pluripotent stem cells in a 10-liter suspension-based and clinically viable process,” Dulgar-Tulloch says. “An impressive finding, as these unique cells are able to become any cell type and hence could be used in countless therapeutic indications.”
Further, Dulgar-Tulloch says the LVV team has scaled up a high-titer suspension culture process that “will help cell and gene therapy manufacturers address material cost and shortage challenges. These results are critical milestones in the process of moving cell and gene therapies even closer to treating patients.”
As for the challenges of working in this field, Dulgar-Tulloch says that a variety of different technologies from many different companies are necessary in a CGT manufacturing workflow.
“Additionally, some solutions do not yet exist or are inadequate to meet the needs of the emerging industry,” he explains. “CATCT is working to advance new solutions to meet these challenges. The team is continually seeking new tools and technologies, from proof of concept to original equipment manufacturer integration.”
One of the pros of working at CATCT is that because the team is made up of both CCRM and GE hires, they can benefit both from each other and expertise across those two organizations.
“The environment is collaboration-focused, as CATCT can leverage both CCRM’s and GE Healthcare’s expertise in business development, intellectual property, process development, and translation of scientific discoveries,” May says.
Being a part of the larger goal of helping people through regenerative medicine is also a plus. “CATCT also aims to ensure that the advancements it creates will benefit the regenerative medicine community more broadly, with the goal of benefiting patients in the future,” May says.
And it doesn’t appear that the strong global focus on regenerative medicine will fade anytime soon. May explains that, worldwide, with recent announcements about clinical trials involving CGT and approvals by regulators such as the U.S. Food and Drug Administration, regenerative medicine has become “a top-of-mind area of science.” He adds that Canada, as a leader in stem cell research and bioengineering, is a big contributor to that success.
“CATCT is playing a key role in maintaining Canada’s leadership position by addressing the solutions that will enable the production of the cells required for successful clinical trials in the CGT industry, paving the way for more regulatory approvals,” May says. Moving forward, he says the center plans to partner with more and more CGT manufacturers to accelerate their therapeutic development.
“As new cell types and new indications are identified, CATCT will be at the forefront of developing cost- and quality-effective solutions to overcome potential roadblocks to their clinical success,” he concludes.