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May 12, 2021

Outsourcing to a contract development and manufacturing organization (CDMO) can be critical to success, especially for companies with limited resources. Despite an increasingly crowded field, selecting the right CDMO partner that caters to your specific needs is a complex decision.

CCRM provides innovative​ CDMO services to enable the development and commercialization of cell and gene therapies, and regenerative medicine-based technologies. We offer a customer-focused approach that’s tailored to each client. We solve the big challenges in cell and gene therapy through the seamless integration of four pillars: extensive expertise, enabling technologies, collaborative processes, and specialized infrastructure.

In this blog post, we’ll explore how these four pillars guide our work with our clients, with examples from two of our clients, Avectas and DiscGenics.

 

Extensive Expertise

Our team is comprised of over 135 employees, including dedicated scientists, process engineers, operators, quality staff, and others who have years of experience in regenerative medicine, biopharmaceutical development and manufacturing. Our scientific expertise, coupled with our client-centric approach to project management, allows us to help both emerging biotech start-ups and established global biopharmaceutical organizations take their products from concept to market.

Ireland-based Avectas, a cell engineering technology business, was developing a unique intracellular delivery platform to enable ex vivo modified cell-based therapies. The team was preparing its technology for commercialization and required its non-viral cell engineering platform, SOLUPORE™, to be assessed by an experienced third party.

When Avectas employees visited CCRM’s facility in Toronto, Canada, they recognized that our team had the expertise to comprehensively evaluate and further develop their technology. CCRM was able to create novel, high-quality data sets within a short timeframe. Avectas told us that we went above and beyond by delivering results that were outside the original scope of work.

DiscGenics, a therapy developer focused on degenerative diseases of the spine, established a novel process to generate cells for their allogeneic therapy. But with a small group of ten employees, it needed scientists and engineers who could work as an extension of their team and provide bio-process scale-up expertise.

After meeting with members of the CCRM and Cytiva teams, DiscGenics stopped looking. CCRM and Cytiva had experience with the type of equipment DiscGenics intended to use and they quickly fulfilled the mandate.

 

Enabling Technologies

One way that CCRM provides access to cutting-edge, end-to-end technologies is through industry partnerships. We have a variety of equipment from different providers so that we can offer a wide array of manufacturing services and support.

Avectas was impressed with CCRM’s equipment, as well as its proximity to academics and clinicians at the University of Toronto and the city’s world-class research hospitals.

“What attracted us to CCRM was the breadth of processes they have in-house, the equipment that was available, and the expertise of the team on-site,” said Lisa O’Flynn, Director of Process Development, Avectas.

DiscGenics was planning to build its own manufacturing facility, but was not ready to invest in equipment until it knew exactly what it needed. Having access to the state-of-the-art equipment at the Centre for Advanced Therapeutic Cell Technologies (CATCT), operated by a team of CCRM and Cytiva scientists and engineers, meant DiscGenics could focus on its clinical roadmap and determine which equipment it needed to invest in.

 

Collaborative Processes

CCRM offers a collaborative and transparent client-centric approach to problem solving that includes frequent interaction with technical leaders.

For Avectas, being based in Ireland presented a unique challenge, especially when international travel restrictions due to the COVID-19 pandemic prevented its staff from visiting the CATCT facility in-person while work was being done. Despite these restrictions, the two teams worked together to manage a seamless virtual technology transfer and meet multiple aggressive deadlines. This collaborative relationship allowed Avectas to move its SOLUPORE™ technology closer to the clinic and streamline the path towards commercialization.

DiscGenics had a small team with limited resources, so the opportunity to engage with CCRM’s experts, who have years of experience, and who are capable of doing bioprocess scale-up and assay development was a deciding factor in working together. Throughout this long-term relationship, CCRM accommodated frequent change requests and various statements of work so that DiscGenics always had the flexibility it needed.

Since each cell therapy is distinct, DiscGenics appreciated CCRM’s willingness to incorporate input from their team, resulting in a very collaborative relationship. CCRM functioned as an extension of the DiscGenics’ team, helping craft the scope of the work and delivering on key milestones.

“We’ve come a really long way in a few short years and I think a lot of that is thanks to the relationship we had with CCRM and Cytiva. They were the launching pad to get us from the clinical stage to our future commercial process,” explained Lara Ionescu Silverman, PhD, Senior Director, Research and Development, DiscGenics.

 

Specialized Infrastructure

Known as a Canadian centre of excellence in cell and gene therapy, CCRM’s 40,000 square foot facility is located in the heart of Toronto’s Discovery District. It offers both process and product development and Good Manufacturing Practices-compliant facilities to provide continuity of process from lab to clean room, and facilitates essential communication between these two functions.

Avectas saw CCRM’s location as a big advantage in terms of its proximity to many potential adopters of the SOLUPORE™ technology.

DiscGenics found CCRM’s lab so well-equipped, organized and maintained, that it was used as a model for DiscGenics’ own facilities.

Learn more about our innovative CDMO services, and our work with Avectas and DiscGenics.

Please contact us to find out how CCRM can support your cell or gene therapy product.

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