The Impact of Automation on Costs and Variability

In a video interview with Pharma Commerce, Jason C. Foster, CEO of Ori Biotech, describes how the current state of cell and gene therapies (CGTs) shows promising potential, particularly in curing cancer and rare diseases. These therapies are safe and effective, with evidence demonstrating their curative capability. However, their widespread adoption is hindered by challenges in manufacturing at large scales and at affordable costs, limiting patient access. While three CGT products have advanced from last-line to second-line therapies, the number of patients receiving treatment has remained relatively unchanged, signaling that access, not prescription willingness, is the primary issue.

Only about 10,000 patients were treated with CGTs in 2024, out of a much larger global pool of patients who could benefit, with access in the United States at just 20%, and far lower in other regions. The real obstacle is the inability to produce these living, often personalized therapies at the scale needed for broader distribution. Many existing production processes rely on outdated technology that cannot meet the demand or provide the level of access needed.

This situation creates a vicious cycle: limited access leads to doubts about the commercial viability of these therapies, affecting investment in future innovations. CGTs cost billions to develop, and investors and companies require financial returns to continue funding new therapies. If the therapies cannot reach the market or gain sufficient coverage, the commercial future of CGTs is uncertain, risking investment in this area and potentially diverting capital to other treatment modalities. Overcoming these manufacturing and access barriers is crucial for unlocking the full potential of CGTs and improving patient outcomes globally.

Foster also comments on the manufacturing bottlenecks; regulatory hurdles; role of automation; and economic and healthcare system challenges pertaining to CGTs.

A transcript of his conversation with PC can be found below.

PC: How do you see automation playing a key role in improving efficiency, reducing costs, and ultimately, expanding patient access?

Foster: A broad church of automation has quite a lot of differences within it. Some people think the robots are coming to save us. Unfortunately, the robots are not coming to save us. Having a robot arm move one thing from one place to the next adds minimal value in the whole scheme of things. Ultimately, when it comes to automation, people always tend to use a car analogy, the Toyota manufacturing line idea or concept, which is not far off.

Essentially, what you're doing is you're replacing human beings that are highly skilled, very expensive, and that they're not enough of, with machines. And the machines are very good at doing the same thing over and over again in the same way every time, and not introducing variability, which human beings are not very good at. No matter how expert we are, we tend to introduce variability because we're human. What the new generation of automation technologies like Ori’s, which is called the IRO, essentially automates that bottleneck, that core bottleneck we were talking about, which is seven to 10 days of a standard CAR-T manufacturing process. It allows us to do the same thing every time. To sterilely move fluids from one step the next inside the system, the cells stay in optimal cell growth conditions, so you can shorten processes. The way we are able to increase throughput and decrease variability while decreasing cost is decreasing labor. The first cut is that we take about 60% of the people needed out of the process, which is great, because those people are highly skilled and can be doing lots of other high-value things, besides micro pipetting under the hood or tube welding. Those things are not value added.

Let’s get the automation technology to do that, and then the remaining 40% of labor is de-skilled. You have a high school graduate, technician-level person, versus a PhD immunologist, of whom there aren't enough of, so that labor equation shifts dramatically. A lot of the cost savings that I just quoted you—that 50% cost reduction—comes from labor.

The other big bucket where the costs come from, equally, are driven by automation, which is, we're much more efficient at using those very expensive reagents that go into the process. They’re the ingredients, if you will. If CAR-T was like baking a cake, you've got media which feeds the cells. You've got activation reagents, which are very expensive. You've got growth factors, cytokines, which are very expensive, you’ve got viral vector, which is very expensive. Can we use those inputs much more efficiently, so that we can use less of them as an example and therefore drop the costs and still get that same safe and effective product out? We've demonstrated with our automation technology that we're able to use—just as an example—about 116^th of the amount of media. So we use one liter, versus some processes which use 16 liters. Like a perfusion bioreactor, where it's just kind of washing through the system, we can use about 25% of the viral vector. We've demonstrated you can get the same number of CAR-positive cells, so CAR-T cells out of the process, using a viral vector MOI of 0.25 as you would use today in a process, using an MOI of one, so essentially 75% less viral vector. And that in and of itself is a massive cost savings. The ability to drive costs out of the system, have repeatable, reliable, scalable processes that we do the same thing every time, no matter where we are in the world, and how many manufacturing facilities we're working in, is part of the key that automation unlocks, and that's one of the ways in which we envision a future where tens of thousands and then hundreds of thousands of patients get treated every year.