Fabian, we know that there are over 1,000 cell and gene therapy candidates presently being developed for the treatment of various diseases. What is the demand for cell manufacturing and where does Cellares come in?
The inception of Cellares can be traced back to the commercialization phase of cell therapies that began around 2017, with the FDA approval of the first genetically modified CAR T cell therapies. By 2019, witnessing the burgeoning demand for scalable, automated cell manufacturing technologies during various cell therapy exhibitions, my Co-Founder, Omar Kurdi, and I realized the significant gap in the market. There were more than a thousand cell and gene therapy candidates in development, but a stark absence of technologies capable of meeting the industry's needs for high throughput manufacturing and cost reduction. This realization led us to establish Cellares, aiming to revolutionize the cell therapy manufacturing landscape by integrating all the steps of cell manufacturing into a single machine that provides end-to-end automation and high throughput.
Cellares calls itself an Integrated Development and Manufacturing Organization (IDMO) instead of a Contract Development Manufacturing Organization (CDMO). What is the difference between these two?
The key difference between the Cellares IDMO and conventional CDMOs is a 10x improvement in productivity, meaning that with the same number of employees and the same amount of floor space, we can produce 10 times more cell therapies than any other contract manufacturer. We have achieved this by developing a novel cell therapy manufacturing platform called the Cell Shuttle, which reduces required labor and required facility space by 90%. Remember, these drugs are for patients who are dying, they are on waitlists for approved therapies, but due to manufacturing constraints, they can’t get the latest therapies. Cellares will meet the global patient demand, by deploying and operating Cell Shuttles in our IDMO Smart Factories around the world. Our leadership is focused on getting cell therapies to patients as fast and cost-effectively as possible.
Could you expand on that last point? Are you suggesting that patients today die, not because of the lack of treatments, but because of slow manufacturing?
Yes, it is a problem that deserves more attention. The cell therapy industry is grappling with issues of scalability, cost, and quality. About 20% of patients are dying on the waitlist even though they are eligible for approved cell therapies because the industry is unable to meet patient demand. This is largely due to the lack of automated, high-throughput cell therapy manufacturing technologies. Traditional cell therapy manufacturing processes are manual, labor-intensive, and not suited for large-scale production. Each cell therapy dose is made by hand for one patient at a time, by a team of technicians using manual methods and benchtop equipment. These manual processes are labor intensive, costly, failure prone and impossible to scale.
About 20% of patients are dying on the waitlist even though they are eligible for approved cell therapies because the industry is unable to meet patient demand.
What is the Cell Shuttle?
The Cell Shuttle automates and integrates the entire cell therapy manufacturing process into one place. It encapsulates the functionality of approximately 100 benchtop instruments in a single, compact machine. This integration allows for the automation of the entire cell therapy manufacturing process, from cell activation to formulation, in a closed system that minimizes contamination risks. Our proprietary technologies include a counterflow centrifugal elutriator, a magnetic cell sorter, an electroporator, a bioreactor our proprietary sterile liquid transfer technology. Integrating all of these technologies in a compact and automated solution reduces labor and space requirements by 90%. The other key difference is that the Cell Shuttle can process 16 cell therapy processes simultaneously. That is 16 times higher throughput compared with any benchtop instrument.
We are ambitiously expanding, taking on new partners like Bristol Myers Squibb and building Smart Factories. Our facility in Bridgewater, New Jersey, is capable of housing approximately 40 Cell Shuttles and producing up to 40,000 patient doses annually. In Europe, we have a facility in Belgium which will become operational by the end of 2026.
Our strategy for global expansion and meeting the worldwide demand for cell therapies is multifaceted, involving shared capacity, dedicated capacity, and dedicated facility models to cater to the various needs of pharma companies and biotechs.
Looking five years into the future, where do you see Cellares in the cell therapy manufacturing industry?
In five years, we envision the Cell Shuttle will be the de facto standard for cell therapy manufacturing, and we will have successfully addressed the industry's scalability, cost, and quality challenges. We believe that is possible and we have the people to do it.
We just built the first Cell Shuttle that is compliant with current Good Manufacturing Practice (cGMP), which is a key milestone on the way to ensuring clinical readiness by the end of 2024.
