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The BRIDGE@CCRM: Where cell and gene therapies go mainstream
By Shawn Lawrence
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the Bridge@ccrM:
WHERE CELL AnD GEnE THERAPIES GO MAInSTREAM
On January 13, 2016, the Government of Canada and GE Healthcare announced that they were each investing $20 million into the creation of a new Centre for Advanced Therapeutic Cell Technologies. Located in the heart of downtown Toronto in the MaRS West Tower, the new facility, dubbed BridGE@CCRM, is scheduled to be up and running by the late fall and expectations are that it will usher in a new era of industrialization in the regenerative medicine field.
The Canadian Press Images/Centre for Commercialization of Regenerative Medicine/Salvatore Sacco
As Michael May, president and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), explains it will be a unique venue where solutions like scalable manufacturing processes for cell therapies are developed to help regenerative medicine companies, both big and small.
“We’re taking a unique approach to developing and testing new manufacturing and workflow solutions,” says May, adding that the way it has been done in the past, companies take a bright idea, create a prototype and throw it over the fence and see what customers think. “Here companies like GE and others will work handin-hand with the customers and end-users on the ground in creating the prototypes, and thus enable scalable, commercialized manufacturing of such therapies.”
Moreover, he says with GE as a partner, there is huge potential to capitalize on existing expertise and credibility in the industrialization space.
“I think the wonderful thing about this collaboration is that GE is one of the most significant infrastructure companies in the world. It already enables industrialization in so many other major industries. GE Healthcare’s Life Science business already provides tools and technologies to people throughout the various parts of the market including basic research all the way through to clinical production and manufacturing,” he says.
On the other side of the table, Phil Vanek, general manager of cell therapy technologies at GE Healthcare’s Life Sciences busi-
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— Phil Vanek
ness, is equally boastful of the merits of partnering with CCRM on this initiative. Vanek cites Canada’s rich history in regenerative medicine and existing critical mass of companies in the space as driving factors behind the collaboration.
“Undoubtedly Toronto’s existing excellence in this field, and CCRM are well known in our industry.”
He adds that BridGE@CCRM fits very nicely with GE’s cell therapy business ambitions, but more importantly it is the right response to a growing need in the industry. Specifically that due to cell therapy’s relatively recent emergence as a therapeutic area, it is under-developed in terms of the industrialization technologies available to end users in this space. He believes there’s a huge opportunity for BridGE@CCRM to fill this gap.
“It all starts with what’s currently available to cell therapy makers for meeting their manufacturing needs. The choices are very limited. As an example, autologous cell therapies or what we call vein-to-vein individualized treatments currently rely on tools adapted from other industries such as cord and blood processing, banking, cell culture etc. For many, it’s like cobbling together a factory floor with parts that aren’t designed to work together.”
Vanek says BridGE@CCRM will give GE Healthcare the chance to work directly with end users who are bringing cell therapies to market. It will also allow GE to be more efficient in advancing new technologies. A key part of the collaboration is that it is open to other partners and that the expectation is that therapeutic providers, companies or clinical researchers who have products that they want to bring through the clinic would utilize this centre to future proof their processes.
“We’re absolutely looking for other companies, whether they’re therapeutic companies that need those solutions or companies developing them,” states May. “That is why this centre is so unique, because it gives companies in the trenches reach to the customers, clients, patients and clinical trials.”
According to Vanek, GE’s willingness to work with other companies is two-fold. It comes down to, first, being on the front lines and finding those solutions while creating a place where prospective technologies can be tested out in a real world setting, with access to experts, ideas and customers, and getting to know what the real pain points are so that BridGE@ CCRM can tackle them.
“We recognize that within any manufacturing workflow there will ultimately be multiple components from multiple different providers of tools and technologies, and not just from GE,” he says. “We acknowledge that we won’t develop everything, so in certain areas we want to collaborate and try new things out, and work in a real-world cell therapy production environment workflow.”
Both May and Vanek stress this will be a safe environment for third parties to come and work with GE Healthcare and CCRM.
On the topic of those points of pain, Vanek and May say one must first understand what exactly cell therapies are. As the name implies, they are therapies that use cells to treat disease or replace tissue and there are many different types. In many cases, cells are genetically engineered to make the product. This is where many of the logistical challenges exist, say both men, at the interface of biology and engineering, especially in terms of scale up and scale out. One major challenge that must be overcome is developing a therapy that provides the right kind of cells in the right quantity.
In terms of what is meant by scale up and scale out, an example of the latter is autologous therapies, where cells are removed from a patient and then returned to the patient after they’ve been manipulated to serve a certain function. Vanek breaks it down further into processes. “A lot of times when people think of scaling up, they think just of producing more cells, but scale up for cell therapies also includes additional upstream and downstream processes,” he says. “Upstream processes are all about isolating from a mixture of cells the right cells you’re interested in, or selectively sourcing the cells and banking them. Downstream processes include things like further purifying the cells, freezing them or preserving them so that they can be transported all over the world.”
In terms of challenges to scale up, both say that current manufacturing technologies simply can’t keep up with the high demand for quantity or throughput.
“Whether for financial reasons, or limitations in the technologies, we don’t have the ability to produce enough cells to treat the patients that need them,” says May. “One challenge is that most cells are grown on petri dishes in two-dimensions, on a surface, and when they fill up the surface you scrape them off and regrow them and you’re limited there by the surface area. So to get billions and billions of cells, you have to have rooms full of petri dishes, which are very expensive.”
Vanek offers up immunotherapy as a poster child for this expensive bottleneck.
“There’s lots of great clinical success and many companies have been formed on the backbone of this T-Cell immunotherapy technology, but if you look at where we are today in the market, it’s in the hundreds of patients that have been treated and yet the therapeutic promise for these therapies is going to have to address hundreds of thousands if not millions of patients,” says Vanek. “Ultimately, we have to take the industry from a position where we have the capability and wherewithal to treat hundreds to the point we’re able to treat the millions and that means improving the manufacturing process.”
Another challenge they hope to tackle at the new centre is finding ways to integrate the data side into the liquid side of the manufacturing process.
“The world is becoming much more digitized and so are the data on these cells, their genomics, proteomics, etc. They all need to be processed and integrated to do this optimization,” says May.
On the workings of how the deal came
together, May points to CCRM’s unique consortia model. He explains that CCRM was created five years ago to accelerate the development of regenerative medicine as well as cell and gene based products. One of the important characteristics of its model was building very large and robust academic and industry networks. One of the major industry partners happens to be GE Healthcare.
“We have built a strong industry consortium of nearly 50 companies to help drive a collaborative approach to realizing the potential of regenerative medicine, of which GE Healthcare plays a leading role,” he says. In fact the two sides had talked often about combining their common interests and complementary expertise in the past. “As with most of the big initiatives, you engage with potential partners many times and then champion collaboration, and if the timing is right, good things can happen,” says May. “This is exactly how things played out with GE and we both saw an opportunity to resource this in collaboration.”
He adds that GE’s deep knowledge of the bioprocessing industry, combined with its global scale and health-care insights, made it the ideal anchor partner for the centre. But both parties knew they needed one more party at the table to get the project launched.
“Ultimately, we tried to figure out a way this could possibly be funded and there was the call from the Canadian government around the FedDev initiative to say, ‘hey, if you can bring a company to the table that’s willing to match the government investment, we would be very interested in having a manufacturing oriented position in Toronto,’” recalls May.
With GE as that partner, government readily backed the centre, and an investment was made through the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) from its Advanced Manufacturing Fund (AMF). The official news announcement for this new facility drew so much attention that even Canadian Prime Minister Justin Trudeau was in attendance for the funding announcement. The reason being, regenerative medicine is a priority even at the federal level for a host of reasons.
As one FedDev Ontario spokesperson explains, BridGE meets many of the objectives of the AMF fund, specifically in terms of supporting the development of cuttingedge technologies to improve processes
Legend
Meeting
Offices
Cubicles
Carrels
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Storage/Mech/Comms and increase productivity, establishing clusters and creating collaborations between the private sector and research and post-secondary institutions.
“The project was assessed against the AMF guidelines and determined to be a good prospect for investment on the basis of three criteria: level of innovation, market relevance and the potential for spill-over economic benefits,” said the spokesperson.
Among the spill-over economic benefits that are anticipated from BridGE is the creation of 209 full-time jobs as well as the maintenance of an additional 180 fulltime permanent jobs in Ontario. The presence of a successful global company like GE Healthcare is also considered a huge win for Ontario in terms of strengthening its economic position. Moreover, experts already forecast that the global market for cell-based therapies will surpass the US$20 billion mark by 2025, with an annual growth rate of 21 per cent. BridGE@ CCRM presents a huge opportunity for Canada to capture this growing market.
Ultimately, says May, by having access to new technologies developed at BridGE@CCRM, there is also potential down the road to eventually build even larger manufacturing facilities in Ontario for this burgeoning subsector.
“The idea being that processes developed at BridGE@CCRM would be transferred over to these plants that could be built here if all goes well,” May says. On this point, May says that the manufacturing success of BridGE@CCRM has potential to create stickiness for other companies in the regenerative medicine space.
“If they manufacture here, they’ll likely stay here,” he says.
Programme Requirements Room Area # Required Actual Exec Office 4 4 Offices 6 6 Cubicles 15 11 Carrels 55 45 Boardroom 1 1 Meeting Rooms 5 5 Kitchenette 1 1 Lockers 70 70 Storage 1 1 Filing Cabinet Pods 2 6 Printer Pods 2 2 IT Closet 1 1 CCRM MaRS 10th Floor
Adjacent Tenant Space Preliminary Program Layout Plan
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He adds also that the new technologies and devices tested at the facility by academic partners might also one day be bundled to create new companies. It all fits very well into the larger CCRM puzzle of creating a sustainable regenerative medicine cluster.
Already we’re seeing the model work. For example, on CCRM’s 40,000 sq. foot floor at MaRS is BridGE@CCRM and CCRM already has a partnership with UHN to operate a GMP facility to make cells for early stage clinical trials. Also sharing floor space is the University of Toronto’s Medicine by Design, a $114 million academic initiative to create new discoveries and technologies at the front end of regenerative medicine. And again on the same floor there’s the headquarters for the Ontario Institute for Regenerative Medicine (OIRM), a provincially funded initiative that brings together all of the institutions and most of the scientists in the field. CCRM is the commercial partner for both of these initiatives: Medicine by Design and OIRM.
“It really is part of our overall strategy to leverage this activity and collaboration into bringing the best investments to town, and we don’t like to sit still,” says May.
He adds that while there are a lot of collaborations going on the world where one plus one equals two, everything that CCRM is doing here is driving towards one plus one equals 10.
“I think that bringing all these things together, with everything else we’re doing, demonstrates that it’s possible,” says May. “Canada discovered stems cells, and so really we should be a leader at making them and I think this facility is a a means to make this happen.”
Vanek is equally excited by all this activity.
“This partnership has been well received by the industry and GE leadership. We’re very excited about cell therapy and this is a great first step for GE to help industrialize the cell therapy industry.”
To see this story online visit http://biotechnologyfocus.ca/ made-in-ontario/
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