Paper is the enemy of scale in CGT manufacturing, says Ori Biotech

Ori Biotech says its paperless platform eliminates waste and reduce costs, which could potentially improve patient access to cell therapies.

The London-based firm Ori Biotech formed in 2019 with a main goal of enabling extensive patient access for CGT therapies through its scalable bioreactor and fluid handling platform, which hopes to to automate, digitize, and standardize CGT production.

The platform remains in stealth mode. However, this has not put off investors who backed the company’s $100 million Series B funding in January to expand all functions of its CGT platform.

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The biggest obstacle to achieving wide patient access is the high cost, low throughput, and highly variable manufacturing process, which typically dominates the CGT space.

Ori’s CEO Jason Foster told BioProcess Insider at Advanced Therapies week, Miami that “People will say costs don’t impact pharma pricing [and] those things aren’t related. But if you can make products less expensive, higher throughput and there is more of them available, these kinds of laws of supply and demand start to come into play, where we can price more aggressively to get better access, and get patients treated.”

An area that needs to be eliminated is the paper trail associated with CGT manufacturing platforms. Ori described “paper as the enemy of scale.” Therefore, the firm looks to “take people out of the process where they’re not necessary, eliminate waste, and reduce costs [by] eliminat[ing] paper from the system.”

“So, our hope is that the platform helps enable that [and] it becomes the default infrastructure for cell and gene therapy product development, and then ultimately, commercialization. That’s what success looks like for us, being able to enable widespread patient access.”

LEAP launch

The firm is also launching its Lightspeed Early Access Program (LEAP), which provides specific partners with pre-launch access to the platform in 2022.

Foster said Ori has used feedback from customers from the very beginning about their needs and what they want to ensure they have an adaptable and dynamic product before they commercially launch.

“That’s really what LEAP is about. It’s the kind of culmination after two years to say we’ve heard you, we’ve listened to the market, and we want to make sure we’ve gotten it right. These are the partnerships that will continue with let’s say five, maybe six participants in the lightspeed program. We’ve got four committed, and then a couple more that we’re looking to sign up,” Foster told us.

While the firm is backed by huge funding and a paperless strategy it claims can make patient access easier, it also acknowledges the risks associated with launching a platform that does not follow the traditional manufacturing process seen in the CGT space.

“There’s a perception of risk by changing the way we’re doing it. But we’re already taking risk by not doing anything. It’s a balance of what’s risk? And what’s returning? We [must] take smart, calculated risks to try to improve these things,” said Foster.

Scaling up staff

Its platform is not the only thing the firm is looking to scale-up. Ori currently has 32 employees and is looking to increase this number to 65/70 by the end of this year and then potentially double this number in 2023.

“We’re really hoping to scale the team up bringing in experts in their specific domains. We’ve hired people from the contract development manufacturing organization (CDMO) world that have provided services to therapy developers and lots of other places that really are experts. And part of the value that we hope to bring our partners is that expertise,” Foster said.

Foster said though it isn’t easy to recruit in the current climate, Ori is “flexible as to where people physically sit, which is absolutely an advantage. And one of the things we won’t do is compromise on the quality of the team.”