Just a few months after the reveal of Ori Biotech’s automated cell and gene therapy manufacturing platform IRO, the technical expert is doubling down with one of its chief allies.
Early Wednesday, Ori unveiled a collaboration with influential contract development and manufacturing organization (CDMO) Charles River Laboratories to showcase the benefits of Ori’s next-generation production platform.
Specifically, the companies are showcasing new biological data from IRO comparing the Ori system to a process optimized by Charles River for CAR-T therapies using alternative manufacturing technology, Ori and Charles River said in a release.
The new data were presented in Boston Tuesday by Ori’s CEO Jason Foster and Matt Hewitt, Ph.D., chief technical officer of Charles Rivers’ manufacturing business.
IRO is designed to automate, digitize and standardize some of the most time-consuming and labor-intensive parts of the cell and gene therapy manufacturing process. The system is trifold, comprising a novel bioreactor system, automation and the platform’s cloud-native digital component, Foster told Fierce earlier this year.
The physical instrument in Ori’s manufacturing platform is about the size of a microwave oven and can be stacked vertically or horizontally to build capacity. Ori believes IRO could help slash development timelines, reduce labor by up to 70% and cut cost of goods by up to 50%, according to the release. Moreover, the company figures IRO can help reduce processing times by roughly 1-2 days over current approaches and bring down tech transfer timelines from months to just weeks.
So far, the data generated on IRO by Charles River look promising.
With minimal process optimization, the IRO platform performed at least as well in some metrics and outperformed the current process in both cell growth and total CAR+ cells out of the box, the companies said in their release.
Overall, IRO was able to hit 51% CAR+ expression and 2.1 billion total CAR+ cells in seven to eight days versus 1.6 billion total CAR+ cells using Charles Rivers’ legacy tech.
Looking ahead, Ori and Charles River plan to continue their collaboration as part of a joint mission to ensure next-generation cell products have IRO platform access across clinical development and commercial scale-up.
“To me, part of our value proposition is understanding and having experience with all the technology that is out there,” Hewitt said in an interview, pointing to Charles Rivers’ motivation behind the Ori team-up.
Hewitt, who shifted over to Charles River from Lonza’s personalized medicine business, is no stranger to the field, either, having set off in advanced therapeutics working on the gene therapy side before a broad market pivot to cell therapies several years later.
When Ori unveiled its LightSpeed Early Access Program (LEAP) to let experts test out its platform back in 2022, “we kind of jumped at the chance to be involved,” Hewitt explained.
And, while the personalized medicine space was still the Wild West some 10 years ago, the need to overhaul traditional manufacturing approaches persists to this day, Hewitt said.
“There are a lot of patients that aren’t able to benefit because we’re at a point where we physically cannot produce enough doses,” Hewitt explained.
Foster echoed Hewitt’s sentiments during the interview.
“Anything, in my view, that limits flexibility is going to be bad for the industry,” he said. “We need things that enable flexibility, enable people to take this piece and that piece and put them together in a way that makes sense.”
As for whether Ori and Charles Rivers’ latest collaboration is a continuation of their LEAP work or something altogether new, “I think it’s a bit of both,” Hewitt said.
Meanwhile, testing and validating Ori’s IRO platform outside the company’s own facilities isn’t about saying one piece of tech is better than another, the Charles River exec stressed. Rather, it’s about gaining familiarity with the breadth of manufacturing options available today to help offer a platform best-suited to the specific client’s needs.
While LEAP was more focused on premarket testing, feedback and data generation, Ori’s goal moving forward is to work directly with biotechs, pharmas and third-party developers in a bid to wed Ori’s technical expertise with other companies’ drug development know-how, Foster explained.
“I think moving forward from here, there’ll be a great opportunity for three-way collaboration with Charles River, Ori and then the cell and gene therapy community to really improve accessibility in these therapies,” the CEO added.
As for Charles River, “we continue to want to use [IRO] for client processes,” Hewitt said, noting that Charles River is now producing multiple commercial personalized medicines for the U.S. and Europe.
As Charles River continues to grow, it’s reached the point where it’s looking to scale its cell and gene processes and expand its footprint, Hewitt added.
As part of that process, “we’d like to align as much as possible across systems and equipment and then procedures,” he said, pointing to the benefit of a platform like Ori’s.
As for another added perk, simpler manufacturing equipment would also make production work for cell and gene therapies “more approachable from a talent perspective,” Hewitt pointed out.
“If we wait for Ph.D.s, we will never have enough talent, the prices of these therapies will never get substantially better,” Hewitt said, adding that when it comes to manufacturing jobs, “we should be treating this like a trade, like anything else.”
Since the IRO platform’s launch at the annual conference of the International Society for Cell & Gene Therapy in May, Ori has deployed the platform with two partners, Foster said.
Within the next four to six months, the company expects to have 10 partners up and running on the platform.
Ori Biotech is hardly alone on its quest to automate cell and gene therapy production.
In April, Cellares scored a major break when it inked a $380 million deal to provide CAR-T manufacturing space for Bristol Myers Squibb utilizing its compact, automated cell therapy manufacturing units. Plus, Cellares' innovative platform is also being investigated by Gilead Sciences' Kite unit.
Elsewhere, Multiply Labs' robotics platform recently yielded a partnership with Thermo Fisher Scientific.