Spearheading a Paradigm Shift in Cell Therapy Manufacturing

By Fabian Gerlinghaus, co-founder and CEO, Cellares

Cell therapies are revolutionizing modern medicine. Where traditional treatment methods have failed, cell therapies have beaten cancer into remission for the vast majority of patients with certain hematological malignancies. These types of results are unprecedented with any other class of medicines. After decades of research and development, the approval of the first two CAR-T cell therapies in 2017 marked the beginning of the commercialization phase in the field. With hundreds of trials in the clinic and the FDA projecting 10-20 approvals per year starting 2025^[1], humanity is at the cusp of a new era in which powerful personalized medicines could eradicate many types of cancers that were once considered a death sentence.

Unfortunately, there is one major hurdle eclipsing this bright future — the cell therapy manufacturing bottleneck. Most cell therapies today are produced one single individual dose at a time, using that patient’s cells as the starting material. This approach is very labor-intensive, failure prone and extremely difficult to scale with manual methods. Each dose is expensive to create and can take weeks, which is leaving extremely sick patients waiting for treatment as they are running out of time.

Today, the addressable patient population for CAR-T cell therapies is about 450,000 patients —a figure projected to exceed 2 million in five to 10 years^[2]. Yet right now, even the most pioneering companies in the cell therapy field struggle to treat a few thousand patients per year. Due to the lack of scalable manufacturing technologies, thousands of terminally ill cancer patients whose lives could be saved by approved CAR-T cell therapies are dying unnecessarily.

Furthermore, cell therapy manufacturing is expected to be an $11.6 billion market by 2030^[3], but only 5 to 10 percent of the required manufacturing capacity currently exists^[4]. In short, only a small fraction of patients who could benefit from CAR-T cell therapies are receiving it due to manufacturing limitations.

Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research (CBER) at the FDA said, “Best to contemplate the path toward scale up early on, as sometimes success in this space comes very quickly, and it is a shame when manufacturing scale up must hold a product back from reaching the market.”^[5] In our experience, cancer centers, cell therapy companies and CDMOs understand the importance of having a clear path to efficient large scale manufacturing, but these organizations lack solutions to fully automate their manufacturing processes. As a result, the industry has come to rely on a plethora of benchtop instruments that were never designed for industrial scale cell therapy manufacturing. Instead, if these organizations had access to highly automated cell therapy manufacturing solutions, they could dramatically lower manufacturing costs, accelerate market entry, and scale out production to meet patient demand.

This is where Cellares comes in. Our team recognized the need for innovation to unlock the full potential of cell therapy. We understood that providing manufacturers with automated, adaptable, and efficient manufacturing technology could make affordable life-saving cell therapies widely available to patients in need. This is why I co-founded Cellares along with Omar Kurdi, our president, and Alex Pesch, our chief technology officer. What we’re bringing to the table as a founding team is a successful track record in inventing, developing and successfully commercializing complex bioprocessing technologies. Alongside the entire Cellares team, we’re on a mission to create the future of cell therapy manufacturing. We will accelerate access to life-saving cell therapies by providing a one-of-a-kind solution that will overcome the current manufacturing limitations. To date, we raised $18 million in Series A funding, led by Eclipse Ventures with participation from 8VC and EcoR1 Capital to advance our cause.

The Cell Shuttle is a Flexible, Scalable and Fully Automated Manufacturing Solution

Today, cell therapy companies have limited options, but Cellares is shifting the manufacturing paradigm. With the Cell Shuttle, biopharma companies, academic research centers and CDMOs will no longer have to compromise by either choosing a manufacturing platform that is semi-automated but lacks workflow flexibility, or one that provides customization but not the end-to-end automation needed to manufacture at scale. Instead, the Cell Shuttle is an automated end-to-end solution, powered by a process design software which allows our customers to create and execute precisely the workflows that define their cell therapy products. This is how Cellares offers the best of both worlds — automation and flexibility.

The Cell Shuttle is the first industrial scale cell therapy manufacturing solution. It’s a customizable factory-in-a-box, which provides our customers with the ability to produce 10 patient doses simultaneously. This is an order of magnitude improvement in throughput compared with any other manufacturing solution on the market today. True end-to-end automation in combination with high throughput is what makes the Cell Shuttle the first solution that enables manufacturers to scale out to meet patient demand. Through automating and closing the manufacturing process, the Cell Shuttle enables a three-fold reduction in process failure rates by eliminating opportunities for operator error and contamination. It also reduces manufacturing costs for most cell therapy workflows by up to 70 percent compared with manual methods, largely by eliminating most of the human labor and drastically reducing cleanroom requirements.

In the context of preclinical process development, the Cell Shuttle enables high-throughput DOE studies in scale-down models to generate insights that help determine the best possible process parameters for each cell therapy workflow. In this way, Cellares is building a single technology platform that meets our customer’s needs from the preclinical phase, through the clinic, and all the way to commercial scale manufacturing. Avoiding the need to change manufacturing platforms eliminates laborious and expensive technology transfer processes, often accelerating market entry by more than a year.

Collaborating with Academia and Industry to Validate the Cell Shuttle

As part of our strategy to ensure that our products meet the needs of the industry, we are fostering partnerships with leading researchers, academic centers and commercial organizations to inform, test and prove the Cell Shuttle’s broad applicability. In October 2020, we announced our first partnership, when the Fred Hutchinson Cancer Research Center in Seattle joined our Early Access Partnership Program (EAPP). Fred Hutch is a pioneer in the research and development of cell therapies for the treatment of cancer and other life-threatening diseases and is an ideal strategic partner to help validate the Cell Shuttle and ensure it overcomes the challenges associated with current cell therapy manufacturing processes. Fred Hutch will provide Cellares with valuable insights into key manufacturing workflows for CAR-T cell therapies, natural killer cell therapies, and other cell therapy modalities. Fred Hutch will also participate in user studies, inform system specifications, and provide feedback on the Cell Shuttle to help ensure product-market fit.

We are proud to have also assembled a world-class Advisory Board, comprising leading experts in the field of cell therapy, including Dr. Carl June, director of the Center for Cellular Immunotherapies at the Perelman School of Medicine at the University of Pennsylvania. He is widely recognized in the oncology field for his groundbreaking work in the development and commercialization of T-cell therapies, including collaboration with Novartis AG on the first FDA-approved CAR-T therapy, Kymriah^®. Our board's insights are invaluable in guiding the further development of the Cell Shuttle.

Today, cell therapy companies are struggling to meet market demand for their approved therapies due to the lack of scalable manufacturing technologies. In the current paradigm, a team of highly trained professionals step through a complex manufacturing process, typically executing on the order of 50 manual processing steps while spending about 80 hours of touch time and two weeks in very expensive clean room space. This laborious process produces one cell therapy for one patient — costing hundreds of thousands of dollars per dose.

At Cellares we are solving these challenges by spearheading a paradigm shift in cell therapy manufacturing. We are bringing together our passion, expertise and knowledge to create the next-generation cell manufacturing platform that offers true walk-away, end-to-end automation enabling our customers to dramatically lower manufacturing costs, accelerate market entry of their drugs, and scale out manufacturing to meet patient demand. In this way we’re accelerating access to life-saving therapeutics, making them more affordable and widely available to patients in need.

For more information, visit cellares.com.