Fabian Gerlinghaus and Omar Kurdi — Founder Story

We’re on a mission to meet the total patient demand for cell therapies globally. Over the next decades, millions of patients will live who would’ve otherwise died because of the collaboration between Cellares and our pharma partners.

Cell therapy is a new type of cancer treatment where a patient’s immune cells are genetically engineered to target and destroy malignant cells. It may sound like science fiction, but this scientific breakthrough has captured the medical community’s attention for good reason: these one-time treatments have led to cancer-free patients for 10 years and counting.

But getting cell therapies to the people who need them remains a challenge. Because each dose is manufactured for a single patient, the manufacturing process is expensive, lengthy, resource-intensive, and often error-prone. Indeed, teams might spend weeks working in clean rooms, performing dozens of manual processing steps with different instruments just to create a single batch for a single patient.

These constraints have real consequences. An estimated 20% of patients eligible for FDA-approved CAR T cell therapies die on the waitlist before they can receive treatment. And each dose of cell therapy can cost more than $300,000 to manufacture.

Enter Fabian Gerlinghaus and Omar Kurdi, who co-founded Cellares in 2019 intending to change that narrative.

The pair have spearheaded an innovative solution that pharma companies are now incorporating to make cell therapies in a timely, cost-effective way, allowing them to scale to meet growing patient demand. Cellares’ high-throughput cell therapy manufacturing platform is fully automated, allowing 16 independent batches to be manufactured simultaneously. What’s more, it closes the manufacturing process from start to finish, improving quality and enabling manufacturing to move outside of clean rooms which are expensive to build and operate.

The centerpiece of the Cellares system is a consumable cartridge that contains modules for all the unit operations required to make a dose of cell therapy. Technicians load the starting materials into the cartridge, which is placed into a self-contained factory called the Cell Shuttle which is roughly the size of a truck. An automated, closed process then eliminates any opportunities for operator error and contamination with robotics moving the cartridge from one bioprocessing instrument to the next.

The upside is a reduction in process failure rates by more than a factor of four and a drop in manufacturing costs by up to 50%. Most importantly, the Cell Shuttle enables a 10x improvement in productivity, since it reduces facility space and labor required to produce a certain number of doses by 90%.

We caught up with Fabian and Omar to discuss their paths to entrepreneurship, how their technology aims to revolutionize cell therapy manufacturing, and its potential impact on millions of patients around the world.

Q: Fabian, you have a master’s degree in aerospace engineering. Where did that interest stem from?

Fabian: When I was in high school, I wrote a paper on a program organized by the European Space Agency (ESA) called the Student Space Exploration and Technology Initiative (SSETI). It brought together about 100 aerospace students from all over Europe to build a satellite and ESA paid to launch it into orbit. While researching the paper, I interviewed the head of the propulsion team. When he was talking about putting together a propulsion system, his eyes lit up. That was contagious and I got excited about becoming an aerospace engineer. My career progressed from there. I’m a technologist by training, turned life science tools inventor, turned entrepreneur.

Q: Omar, on the other hand, you wound up studying electrical engineering at San Jose State University.

Omar: Yes, but I had always wanted to be a doctor. That’s until I volunteered at Palo Alto Medical Foundation and found out I’m squeamish when it comes to blood.

Q: When did you shift gears?

Omar: I was working at the Stanford Genome Center where I was working with very intelligent colleagues. One day I was speaking with a guy who I really respected over there, telling him how I’d wanted to be a doctor since the second grade but didn’t know what to do now. He suggested the field of life science tools biotech. He said I’d wind up saving a lot more lives — plus, there’s no blood. That sounded great. I changed my major to electrical engineering so that I could build devices. After graduation, I worked for a couple of startups, including Finesse Solutions and then Synthego, where I met Fabian. The rest is history.

Q: Before getting into that, Fabian, you came to the US to work as a visiting researcher at Stanford University.

Fabian: That’s right. I spent six months at Stanford working on the haptic teleoperation of robots in space. We put together a robotic system that you could remotely control through an interface and would allow you to feel what the robot felt when it touched surfaces. Honestly, I never took that too seriously because I always knew I wanted to get out of academia. I spent a lot of time looking for opportunities and eventually ran into the founders of Synthego, which had just raised $8 million.

Q: It was literally a garage startup at the time. 2014, right?

Fabian: Yes. They had four or five people working out of a garage when I joined. I helped the company grow to more than 240 people over the next 5.5 years and quickly rose through the ranks. I was the Chief Innovation Officer there when I left to start Cellares with Omar in 2019.

Q: Both of you have technical backgrounds, but you wound up at a company that does CRISPR and genome editing. Was it the idea of doing a startup? Or did genome engineering exert a special pull?

Omar: It’s a culmination of all our experiences. Working at Finesse was all about bioprocessing which is at the heart of cell therapy. Fabian ended up working on designing bioreactors and centrifuges at Synthego, tools that also find application in cell therapy. Synthego is focused on genome editing via CRISPR. CRISPR is a key enabling technology for cell therapies and one of the ways of genetically modifying T cells. Cellares is an incredibly interdisciplinary company and Fabian and I have many different disciplines in our professional backgrounds, or should I say, “in our DNA.”

Q: How do you see it, Fabian?

Fabian: What I found as I switched from aerospace engineering to developing life science tools at Synthego was that you don’t need to be a chemist and understand the details of phosphoramidite chemistry to build a great RNA synthesizer. I co-invented Synthego’s proprietary RNA synthesizers, which is what the company uses to make CRISPR-Cas9 genome engineering kits. You need to understand the requirements and then be good at mechanical engineering, software engineering, controls engineering, systems, and electrical engineering as well as robotics — all those disciplines. It’s easy to translate complex chemistry details into simple engineering requirements such as, “The system needs to get this much of this liquid in here while excluding water. You need to minimize how much of the reagent you’re using, and you need to maintain a certain temperature.” In the same way biological processes such as cell therapy manufacturing translate into engineering requirements, and you don’t need to be an expert in biology to build great tools for the life sciences.

Q: So, take me to the moment when you guys compared notes and realized that you shared a similar vision.

Omar: I quit Synthego in November of 2018 and was thinking I wanted to start something. After returning from a trip to Mexico in January of 2019, I got a call from Fabian. We met in downtown Palo Alto and started hashing out ideas.

Q: And you focused on the challenges cell therapy manufacturers had when it came to meeting patient demand for their therapies. Why weren’t they able to come up with a solution? Was it a failure of imagination or more a question of not being able to do the engineering that was required?

Fabian: There are probably 10 answers to that. For starters, the problem was new. The challenge of how to do cell manufacturing at a commercial scale only existed since 2017 when the first cell therapies were FDA-approved. Timing really matters in business. Starting Cellares in 2019 was great timing. Also, I think a lot of other players were thinking too small. To this day competitors are designing and building low-throughput benchtop equipment that doesn’t scale. They hadn’t realized that a big and meaningful change had happened in the world. They hadn’t fully understood the magnitude of the problem and the immense scope of innovation and ingenuity that it would take to solve this problem.

Q: What was the early reaction to your ideas?

Fabian: A lot of pushback. Investors and customers alike told us, “Hold on guys. There are entire companies that have been started to build one benchtop instrument that handles one manufacturing step for one patient, and it takes them six years to get that to the market. And you’re going to build five such instruments and integrate them into a super-high throughput, fully automated platform that can handle all manufacturing steps for 16 patients simultaneously, not just one manufacturing step for one patient? You guys are positively nuts.” We said that’s exactly what we’re going to do.

Q: How long did it take?

Fabian: Within two years, we built all five instruments. We had data that showed that each of these five instruments worked as well or better as the competing benchtop instruments that were typically being used in the industry. And then in the third year, we put all the pieces together and integrated everything into the first fully automated, fully functional Cell Shuttle. In the fourth year, we put a lot of miles on it and generated a data set that proves that we can run real CAR T cell therapy manufacturing processes while reliably and repeatedly exceeding the release specifications of FDA-approved cell therapies that are on the market. That’s why Bristol Myers Squibb invested in and partnered with Cellares.

Q: How much trial and error was involved in coming up with that solution? How hard was it to make it work the way you wanted?

Fabian: I wouldn’t call it trial and error. I would call it iterations. You only build what we’ve built in the timelines that we had if you’ve got discipline and great processes. You need to go through several design-build-test cycles to learn quickly, but you do it very methodically. There were hundreds of very difficult problems we had to overcome. In addition to following methodical processes, what enabled our success was an intense focus on attracting and retaining truly exceptional talent as well as a strong emphasis on interdisciplinary collaboration in our culture.

Q: As you developed your solutions, how did you calibrate your processes to meet user needs?

Fabian: What you don’t want to do is start with poor user needs and then change the goalpost every six to 12 months. Our goal post was crystal clear from the get-go. The success of such an engineering program rises and falls with the quality of the inputs. So, collecting good user needs was critical. We created a partnership program called the Early Access Partnership Program (EAPP) where several biotechs and cancer centers gave us detailed documentation of their cell therapy processes down to which equipment they were using, the bill of materials, the process parameters, and the critical quality attributes. That wealth of information on a lot of different processes put our scientists and engineers in a position to know exactly what the final machine had to look like and what it needed to be capable of right from the very beginning. That was critical.

Q: What kind of impact do you think this work is going to have as more cell therapies become approved for treatment and there are bigger patient populations?

Omar: We’re on a mission to meet the total patient demand for cell therapies globally. Pharma companies will be able to meet patient demand because they’ve got a manufacturing partner who can scale and meet commercial patient demand. Over the next decades, millions of patients will live who would’ve otherwise died because of the collaboration between Cellares and our pharma partners.

Fabian: We’re making cell therapy viable as an industry. Pharma companies have multiple verticals. They’ve got small molecules, they’ve got biologics, and then they’ve got cell therapies. So, within the pharma companies, cell therapies are competing for investment dollars with two other drug modalities which have a much higher return on investment profile than today’s cell therapies. Most drugs are profitable within six months of being on the market. That is not the case in cell therapy right now.

Q: In a way that works to your advantage.

Fabian: Yes, but for cell therapy to be long-term viable, the manufacturing costs need to come down, and that’s exactly what our technology enables, where a pharma company outsourcing manufacturing to us can expect up to 50% lower price per dose compared with conventional CDMOs (Contract Development and Manufacturing Organizations).

Q: I’m curious about the lessons you’ve learned about yourself as managers and as leaders of a startup.

Omar: The most important thing is that people come first. To be a good leader, you’ve got to understand your team, and what drives and motivates them. That’s vital to creating a vibrant and positive culture where everybody wants to come to work every day. In the future, we believe Cellares will be helping millions of patients, and our investors will receive great returns. But if in the end we all hate each other, then we would have failed as a company. We’d much rather cross the finish line together. A company is not just its mission statement or the technical products that it’s building. It’s first and foremost the people.

Q: As you worked to build that kind of culture, I can only imagine the challenges you had to navigate during the Covid lockdown.

Omar: This company has faced tremendous headwinds. We incorporated in April 2019 and received our first injection of capital in August of the same year. Then within a few months, we’re hit with Covid. At the time, we were only about a dozen employees. Through it all, we tried hard to keep our teams close and connected. For example, we’d shut everything down on Friday evenings, so we could play games as a remote group via Zoom.

Q: Fabian, if you were to share your experience as a founder with someone just starting out, what would you advise?

Fabian: Find an amazing co-founder. Someone who you enjoy working with and who you can trust and rely on. Someone you respect and who is complementary to your own skillset. If you find a carbon copy of yourself, then you’re just going to get in each other’s way, and you’ll want to do the same things. That will lead to worst-case scenarios where you end up in power struggles.

Q: It sounds like things aren’t really slowing down. Is it as intense as it was when you first started, or do you get time to throttle down?

Omar: No. In every startup that I’ve ever been in before this, the gas pedal continues to accelerate and never slows down. It gets faster. If you think about it on Day One, it’s two people, three people, four people. How fast can four people move? Well, today at 170 people, man, we’ve got 100 miles-per-hour winds in our sails. Imagine what it’s like at 5,000 people. Things are rapidly getting more real and much more serious. Your burn rate at two, or three people — you could keep $18 million in the bank for a long time with that many people on the payroll. At 3,000 or 4,000 people, your burn rate is so huge that you better not make any critical mistakes because it could be fatal for the company. There’s so much more at stake now and the bets are only getting bigger. Very exciting times ahead!