In a recent interview with PharmaShots, Fabian Gerlighaus, Co-Founder and CEO of Cellares, shared information on Cellares partnership with Fred Hutchinson Cancer Research Center and unveils how the company is working to get patients the cell therapies they need.

Shots:

• Cellares collaboration with Fred Hutchinson Cancer Research Center is a part of EAPP. Fred Hutch will work closely with Cellares by providing insights into manufacturing workflows for CAR-T cell therapies, natural killer cell therapies, and other cell therapy modalities
• The Cell Shuttle is the first industrial scale cell therapy manufacturing solution
• The main impact Cellares will have is to accelerate access to life-saving cell therapies, by making them more affordable and widely available to patients in need

Tuba: Can we have detail on Cellares collaboration with Fred Hutchinson Cancer Research Center?

Fabian: Cellares collaboration with Fred Hutchinson Cancer Research Center is a part of our Early Access Partnership Program (EAPP). As a partner, Fred Hutch will work closely with Cellares by providing insights into manufacturing workflows for CAR-T cell therapies, natural killer cell therapies, and other cell therapy modalities. The Center will also participate in user studies, inform system specifications, and provide feedback on Cellares proprietary platform to help ensure product-market fit.

Tuba: Are you looking for more organizations to join your Early Access Partnership Program?

Fabian: We are currently in talks with multiple organizations for the EAPP and are very excited about the potential of growing this program with other top tier organizations in the field. At this time, we cannot disclose any more details as conversations are ongoing but will be sure to share future updates with you when we can.

Tuba: Please tell us more about the Cell Shuttle. How it is helping Cellares to make cell therapy widely available and affordable?

Source: Cellares

Fabian: Most cell therapies today are produced for a single patient at a time, using that patient's cells as the starting material. This current process of one dose at a time is very labor-intensive, failure-prone, and extremely difficult to scale with manual methods. Many indications have patient populations of tens of thousands of doses per year, but due to the lack of automated and scalable manufacturing technologies, even the most pioneering cell therapy companies struggle to treat a few thousand patients per year.

The Cell Shuttle is the first industrial-scale cell therapy manufacturing solution. It is a factory-in-a-box that offers true walk-away end-to-end automation  from loading a patient's cells to unloading a cell therapy dose ready for infusion. In contrast to any other cell therapy manufacturing solution on the market today, it has the ability to produce up to 10 patient doses simultaneously. This is an order of magnitude improvement in instrument throughput, which is what is required to help our customers scale-out manufacturing from a few thousand doses annually per drug to tens of thousands of doses annually per drug. In this way, Cellares is helping the industry to make cell therapies widely available for patients.

Another hurdle is the risk of process failure. Many cell therapies today are made-to-order for patients who are terminally ill and have fully exhausted other treatment options. A critical process failure can lead to the loss of a patient's life, because there may not be another opportunity to collect high-quality starting material from the patient for a second attempt. 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.

Because the Cell Shuttle maintains its own cleanroom environment it can be deployed in lower-class environments, which have a significantly lower cost per square foot. It also reduces the amount of cleanroom space that's required by about 80 percent compared with manual methods, allowing for smaller manufacturing sites with higher productivity. By automating the entire manufacturing process end-to-end, further reduces the amount of human labor by up to 75 percent for many cell therapy workflows. Overall, we're confident that we can reduce manufacturing costs by up to 70 percent compared with manual methods, making cell therapies more affordable over time.

Tuba: What makes Fred Hutch an ideal partner to develop Cellares manufacturing platform?

Fabian: For more than four decades researchers at the Hutch have been pioneering treatments for cancer, from the work of Nobel laureate Dr. E. Donnall Thomas to the breakthroughs achieved by Dr. Phil Greenberg, an internationally recognized expert in cancer immunotherapy. The Hutch co-founded Juno Therapeutics in 2013, another leading cell therapy company, and they have a full pipeline of clinical trials including CAR-T cell therapies, natural killer cell therapies, and other cell therapy modalities. As such, they are an ideal partner to provide insights and feedback on our novel technology and ensure it overcomes the challenges with cell therapy manufacturing for the benefit of patients around the world. We have tremendous respect for the organization and are proud to be working with them to advance our mission of accelerating access to life-saving cell therapies.

Tuba: Is Cellares planning to raise more funding in the near future to build its manufacturing technology?

Fabian: To date, we've raised $18 million in a Series A financing led by Eclipse Ventures, with participation from 8VC and EcoR1 Capital. As the CEO, I'm always looking ahead to ensure we have the resources we need to accelerate our mission and make a profound impact on the future of cell therapy manufacturing. We will be sure to share additional financial updates at the appropriate time.

Tuba: How can Cellares make an impact on the future of cell therapy manufacturing?

Fabian: The main impact Cellares will have is to accelerate access to life-saving cell therapies, by making them more affordable and widely available to patients in need.

Additionally, in the context of preclinical process development, the Cell Shuttle enables the high-throughput design of experiment (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, as is usually required, eliminates laborious and expensive technology transfer processes, accelerating market entry by more than a year. The impact that we're hoping to have is to provide patients with access to life-saving cell therapies earlier than they otherwise would.

Finally, there may be an impact on the split between autologous and allogeneic methods. One of the main drivers for allogeneic cell therapy is to increase the number of doses per batch, thus decreasing the cost. That said, autologous approaches have several advantages from a clinical perspective, they're generally safer and the therapeutic effect is more enduring. While the cutting-edge technology we're developing will support both autologous and allogeneic approaches, I firmly believe that it has the potential to make autologous cell therapy manufacturing much more cost-effective and scalable.

Tuba: 'Cellares' revolutionary technology will be a game-changer for the cell therapy industry. Comment on the statement.

Fabian: Hearing Dr. Carl June, the pioneer of the first FDA approved CAR-T cell therapy, Kymriah, say that the technology we are building is 'gaming changing' was a huge vote of confidence. He had just finished reviewing our system architecture in detail when he said this. It certainly solidified the confidence in our approach and further increased our excitement to bring this technology to our customers and help patients.

Tuba: How is the Cellares manufacturing technology different from currently available cell therapy manufacturing methods?

Fabian: The Cell Shuttle is different from currently available cell therapy manufacturing methods in a number of ways. Most notably it's the first solution that allows our customers to scale out to treat tens of thousands of patients annually per drug, without compromising on process flexibility.

The semi-automated systems on the market today lock you into very rigid and narrowly defined workflows. This is very limiting to customers because in cell therapy the product is the process. Cellares is shifting this paradigm by providing biopharma companies, academic research centers and CDMOs with a fully automated platform that integrates modular hardware with flexible software.

The Cell Shuttle has an incredibly modular system architecture so you can configure which processing technologies are on your platform when you order it and even change it thereafter. The modular hardware works in conjunction with a powerful software suite that enables process development scientists to quickly design and execute bespoke cell therapy manufacturing workflows. Users can effortlessly drag and drop cell therapy manufacturing steps into the order that best suits their unique process. In addition, they have full control over all of the underlying process parameters & visibility into a vast amount of data collected throughout the process. We are putting the power back into the hands of our customers, instead of requiring them to work with external application teams for every protocol change. This is how Cellares offers the best of both worlds automation and flexibility.

In the absence of better options, the field has come to rely on companies which make incremental improvements to benchtop instruments that handle one or two processing steps for a single patient at a time. Our scope is much larger. We are providing an end-to-end solution, from loading the apheresis, to automating cell enrichment, cell selection, cell activation, gene transfer, expansion, fill, finish and formulation. What you're unloading at the very end is a cell therapy dose ready for release testing & infusion into the patient.

Finally, one of the biggest differentiators of the Cell Shuttle is its capacity to produce up to 10 unique 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.

Tuba: Is Cellares working on more solutions to overcome the limitations associated with the manufacturing of cell therapies?

Fabian: Right now, we are focusing our attention on continuing the development of the Cell Shuttle to help our customers lower manufacturing costs, accelerate market entry, and scale-out production to meet patient demand. Our long term roadmap includes additional developments that will further the Cellares vision of enabling safe and affordable access to cell therapies for all patients.

Tuba: Do you feel competition in this space? If yes, who would be your potential competitor?

Fabian: There are other companies providing limited automation of some cell therapy workflows.  However, no other technology that we are aware of offers true end-to-end automation, in a closed and flexible platform that is cost-effective and reliable and can scale to tens of thousands of patients annually per drug. This unlocks significant additional revenue for our customers and provides patients with affordable access to life-saving cell therapies. At Cellares we are building the future of cell therapy manufacturing.

About Fabian Gerlighaus:

Fabian Gerlighaus is a Co-Founder and CEO of Cellares. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness.

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