Stem Cell Clinical Trials

New cell manufacturing centre will clear bottlenecks, attract clinical trials.

It can take millions of cells to do the most simple stem cell transplant. Coming up with ways to produce huge volumes of pure, safe cells is a challenge. In mid-January, Prime Minister Justin Trudeau made an appearance at the MaRS Discovery District building in downtown Toronto to announce $20 million in federal funding for advanced therapeutic cell manufacturing to be managed by the Centre for Commercialization of Regenerative Medicine (CCRM), with GE Healthcare also committing $20 million. CCRM’s CEO Dr. Michael May talks about plans for the centre.

Q: How did this come about?

A: This has been evolving over five years as we developed very strong relationships with industry leaders, of which GE HealthcCare is one. As the industry evolves, manufacturing issues are maybe the most talked about bottleneck in cell and gene therapy.

Q: What is your centre going to do?

A: This centre is a business unit of the overall CCRM operation. It has two main activities. One is targeting particular bottlenecks — strategic gaps in the industry — around particular cell types and specific operations and then inventing solutions that can be commercialized as tools and devices. The second thing is the centre will utilize the expertise in the team and the new solutions that will be invented, or technologies that will be integrated, to tackle company problems on a fee-for-service basis.

Q: Can you give a hypothetical example?

A: Any company, large or small, or an academic who is making cells likely has not addressed scale-up and manufacturing in an appropriate way. They are a potential client for not only the solutions we will come up with but also the fee-for-service optimization and scale-up that we will do.

Q: So, if I’m a scientist and I want to do some testing using a particular cell type, but I need millions and millions of cells, I come to you?

A: Yes. We might help in lots of different ways. If there is scale-up that’s needed, we would advise on what needs to get done and create a project around that. And we could hopefully help fund it. It could be fee-for-service or a co-development or any combination.

Q: The space that you have, will scientists be using it themselves or will they be hiring your team to do something for them?

A: It’s not that we would advise them what to do and they would go off to their labs and do it. This will be an advanced manufacturing centre. Our focus with this funding will be our new Good Manufacturing Practice (GMP) facility to make cells for clinical trials. We are going to hire 30 to 40 people to conduct these projects and do this fee-for-service work.

Q: You’ve got GE Healthcare as a major partner, but do you want more businesses to come in?

A: This is a consortium model. GE Healthcare is an anchor partner but we want to bring together and integrate technologies from other sources as well. So, we’re looking for technology partners. But we’re also looking for clients — cell therapy companies that need these solutions. An advantage of the site is it is in such a rich clinical environment in Toronto and, more broadly, Canada. That was a great attraction for GE because it enables them to engage with their customers in clinical trials and projects where the technologies can be stress-tested. This is real-time engagement of the community and the market.

Q: What’s the facility itself?

A: The facility is in MaRS (a not-for-profit corporation founded in downtown Toronto in 2000). It’s going to be part of an entire floor of activities focused on regenerative medicine. There will be the GMP facility there. Our CCRM employees will be there.  It will also be the headquarters for the Ontario Institute for Regenerative Medicine and the University of Toronto’s new Medicine by Design project. So when people enter the 10th floor of MaRS, they are going to see a very integrated, co-ordinated ecosystem in and around cell therapy and regenerative medicine.

Q: Will you be working with other cell manufacturing centres like the one opening in Edmonton, and centres in Laval, Montreal and Ottawa?

A: We’re working with those through CellCAN, that’s one point of contact. I was just in Montreal and promoting the idea of the centre being the process development arm. If we need to optimize or scale up manufacturing we can do it in our centre and transfer those solutions back to manufacturing facilities as needed across the country.

Q: So it’s the Canadian model of working collaboratively, not competitively?

A: Absolutely. Although this will be, within MaRS, a very unique ecosystem, it has to be integrated with other activities across the country. It has to be integrated with other activities across the globe. Trying to achieve the proper scale is impossible with one centre or even one country.

Q: What are the anticipated outcomes?

A: The outcomes will be new technologies and tools to enable clinical- and commercial-scale manufacturing of cells — so there will be very tangible widgets that come out. Over the medium term, there will be a blueprint for cell manufacturing of the future,with integration of a number of technologies. We believe this centre will attract clinical trials to Canada and accelerate the development of technologies and clinical translation so more patients will be receiving cell therapies. It will support companies created in Canada but, as I mentioned, attract companies to Canada. We can’t just talk about scientific leadership anymore. We have to be leading commercialization. We need to be leading translation, through clinical trials. And this piece is manufacturing. Because with manufacturing comes stickiness and companies that are sustainable in Canada.

Q: What do you mean by ‘stickiness?’

A: This is advanced manufacturing; it’s not like making a car that you can diffuse production to the cheapest site in the world. This is an area where the leading edge is still being developed. If we are the leaders in manufacturing cells and those cells get manufactured here, then the companies that are here and the jobs we create here will be sticky.

This post is also available in: German

William C. Hilberg
As an author, Mr. Hilberg has published several papers on health issues that have gained international recognition. He is close to nature and loves the seclusion and activity as a freelance journalist. In his function as editor William C. Hilberg manages the entire content of PENP. Our team greatly appreciates his expertise and is proud to have him on board.