Driving CGT Innovation by Building More Metabolically Fit Cells.
By Sofia Prado-Irwin, PhD
Dr. Shannon Eaker, Chief Technology Officer at Xcell Biosciences, is a veteran CGT scientist with deep expertise in T-cell, HSC, and ES/iPSC biology. He serves on the ISCT Process Development and Manufacturing Committee and advises multiple companies in cell and gene therapy and regenerative medicine through Scientific Advisory Boards.
Orange County Bio spoke with Dr. Eaker about his role at Xcell and his approach to advancing CGT technology from early research through clinical application.
The Interview
OCB: To start, can you tell us about your experience in Cell and Gene Therapy (CGT) and Xcell Biosciences?
Shannon Eaker (SE): I’ve been in the CGT business for over 20 years. A decade ago, everybody was repurposing traditional bioprocessing methods, instrumentation, consumables, et cetera, to fit into the CGT space, which was very tough. I was part of one of the first true cell and CGT groups within industry under GE Healthcare that figured out how to sell bioreactors, cell processing systems, reagents, media, etc., to fit the emerging needs of CGT.
Xcell has been around for about 10 years, but in the last three years we’ve shifted our focus from Research and Development (R&D) to commercial and patient-centered industry. Our technology mimics the tumor microenvironment (TME) and applies a hydrostatic pressure and gas control to mimic in vivo conditions. We can use this for cell line screening, drug screening, and to precondition cells for CGT in vivo applications. The focus has been to take that technology to a GMP (Good Manufacturing Practice) grade product.
OCB: Explain the novelty of the technology that your company is bringing to the industry.
SE: The technology is focused on, “How can we mimic in vivo?”
Cells metabolize small molecules differently when they’re flooded with oxygen and don’t have a hyperbaric pressure versus when they are in a TME. People use our technology when you need to transition an in vitro process as close as you can to in vivo, without actually going in vivo.
Cells struggled to infiltrate into the tumors, mainly because the TME is so suppressive. Why not use our technology for preconditioning cells to go into solid tumors?
Three years ago, the company realized there was an opportunity to apply this technology to preconditioning cells for anti-cancer therapies. Many solid tumor trials were failing. Cells struggled to infiltrate into the tumors, mainly because the TME is so suppressive. Why not use our technology for preconditioning cells to go into solid tumors? Now we’ve brought on a team to make that technology GMP scale. We’re focused on potency and persistency.
OCB: What is the most differentiating aspect of Xcell’s technology?
SE: People already know that the conditions cells undergo when cultured in a TME-like environment are so different than those in a normal environment. But how do you take that deep biological knowledge and transition it into GMP manufacturing?
We’re seeing the inflection point now, it’s becoming more apparent and much more of a focus area. You see the FDA putting out guidance documents around potency and persistency, so they know that’s the next step.
Just growing cells is not good enough.
And look, people just didn’t used to care much about potency, persistency, metabolomics, all these things. I mean, there’s plenty of work that’s being done on the R&D side, I can even mention Nobel Prizes, but there’s that gap in manufacturing. Just growing cells is not good enough.
OCB: What was the development process for bringing this from the scientific concept to an actual product?
SE: We’re a 20-person company of mostly engineers and process development scientists, true R&D and biology-led. We knew that if we wanted to take our technology to the market or to the clinic as quickly as possible, we’d have to work with an external engineering group.
Keeping pressure and controlling gases is not easy, it’s like a submarine challenge. The manufacturing work is being done by Planet Innovation in Australia and the manufacturing will be in Irvine, CA. They’re very well-known, and this was a de-risking decision for us.
The AVATAR Odyssey regulates and alters atmospheric pressure and oxygen concentration for optimal cell type and research.
OCB: As you noted, adoption of new technologies is challenging. What is your plan for getting your technology adopted? How do you approach collaborations at this stage?
SE: We have an advantage in that we have a scaled down, non-GMP model. So people can do R&D and process development work without huge costs.
We also have 200+ incubators of our research use only (RUO) product out in the field. So instead of having a new sales team, making a bunch of beta instruments and flooding the market with them, we already had a handful of people that we knew wanted to go into clinical trials. When we made the device, we tailored it to that specific handful of clinical trial programs. Instead of going broad, we are “white gloving” this handful of customers to make sure that they can get into a patient by the end of the year.
OCB: I would think that’s a slow process, compared to the traditional commercial path. Why is this approach more appropriate for you?
SE: We don’t have a commercial team or marketing team—we’re strong in our technology, so that’s what we’re focused on.
We find people that are focused on the solution that we offer – it’s potency and persistency.
We have to be really mindful of where we introduce our device. We find people that are focused on the solution that we offer – it’s potency and persistency.
OCB: How do you see the technology evolving over the next three, five, even ten years?
SE: Once we get our GMP product into a patient, we’re going to look at everything else within that ecosystem and build upon it. We’re going to have our own media that’s specifically made for TME, better sensors, better consumables, better materials.
Big picture, anywhere anybody is trying to get a more potent product, that’s where we want to be. By the end of the year we want our technology in a patient. We also want it in the hands of a pharma company, a contract development and manufacturing organization (CDMO), and academic institutions—each representing a distinct environment with unique needs, so we can ensure it’s versatile and effective across the industry. In three to five years, we want to be everywhere.
In reflection
Xcell Biosciences under Dr. Eaker’s leadership is making significant strides in CGT innovation. Their unique commercialization strategy—rooted in close partnerships, niche applications, and scientific rigor—sets them apart in the field. Dr. Eaker’s experience exemplifies how creative thinking, problem-solving, and persistence, driven by a focus on patient outcomes, can shape even the most technical aspects of CGT development.