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The Alliance of Advanced Biomedical Engineering reports that a lack of viral vector capacity could stifle the development of promising therapies. But this situation also opens the door of opportunity.

That’s the view of CCRM, a non-profit organization accelerating the translation of scientific discovery into new companies and marketable products for patients with specialized teams, diligence, funding, and infrastructure. The organization is based in Toronto where the biotech sector has been ranked fourth in North America.

CCRM works on internal development projects, fee-for-service, and equity arrangements and has more than 25 ongoing projects, and a significant collaboration with GE Healthcare Life Sciences.

“Our purpose is to work with the local ecosystem of industry and academia, including leading Canadian research institutions, and with our global partners to help shape the cell and gene therapy industry here in Canada and abroad. We want to enable this whole sector and accelerate the successful commercialization of these advanced therapies to help patients dealing with intractable diseases,” says Jana Machan, vp of commercialization for CCRM.

Spencer Hoover, PhD, director of process development and analytics, agrees that there is a bottleneck in the cell and gene therapy field, but explains that CCRM is prepared to address this issue.

“It’s true there’s not enough manufacturing capacity, but it’s not just the physical space. Many of the raw materials, including plasmids, are limited as well. Technical staffs that have the knowhow and expertise to manufacture and develop these kinds of processes are in high demand. So even if you build it, they may not be able to come. It’s not the field of dreams yet,” he tells GEN.

CCRM has been successful because the organization has been able “to identify and recruit experts from neighboring fields, bring them in, and build on our skills in cell and gene therapy manufacturing,” according to Hoover. “This is one area where we have moved the industry forward.”

CCRM is a contract development manufacturing organization (CDMO) that provides technical and business support to therapy developers from concept to market, adds Vanja Misic. PhD, Development Scientist II.

“As an incubator, we offer support from the beginning stages of company creation to branching out on their own. As a CDMO we also engage with external clients at various points in their development and offer our services and expertise to enable or accelerate their programs,” he says.

Notch Therapeutics was incubated at CCRM and recently partnered with Allogene Therapeutics to develop iPSC-derived blood cancer therapies. It was created to commercialize a revolutionary technology that creates allogeneic gene-edited T cells from stem cells on an industrial scale, efficiently making T cell therapies.

CCRM, in partnership with GE Healthcare, has a strong technical team to further the science of cell and gene therapy.

“Our team is dedicated to developing processes for commercial manufacturing of these complex therapies so that they can reach the patients who need them. “From a technical standpoint, we offer many different services to clients. We also invest substantially in developing internal capabilities and we’re committed to continual improvement,” says Misic.

In August CCRM, GE Healthcare, and iVexSol were the first co-recipients of a grant from NGen, a next generation manufacturing granting agency in Canada, to help accelerate iVexSol to commercial-stage production.

“iVexSol is a startup focused on producer lines for lentiviral vectors,” says Spencer Hoover. “We have a partnership with the company, and we are doing work with them around the production of stable viral vectors.”

The CCRM team emphasized that it wants “to help provide regenerative medicine for all.”

“If that’s the goal, we must look at lowering the cost of goods, de-risking technologies, boosting manufacturability, and accessing highly capable development. We also need to support our clients through legal and regulatory pathways,” explains Jason Dowd PhD, vice president, science and technology. “All of these components are in the mix and what we offer.”

 

Reach CCRM at www.ccrm.ca/cdmo-contact.

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