The Role of Automation in Industrializing Cell Therapy Manufacturing
Dr. Dan Strange discusses how automation will be key to scaling up the production of life-saving cell therapies.
Industry Insight
Published: October 21, 2024
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Cell therapy refers to the transfer of cellular materials, either from an autologous or allogenic source, into a patient for therapeutic purposes. Key advances in understanding and genetic engineering of stem- and non-stem cells have led to a series of cell therapy approvals, providing life-saving treatments.
As cell therapies move from niche treatments to widely approved solutions for diseases like cancer and sickle cell, there is a growing need to manufacture these therapies for tens or hundreds of thousands of patients. However, modifications of current methods are needed due to inefficiencies, and the need for vast space, labor and capital in producing cell therapies.
Technology Networks spoke to Dr. Dan Strange, CTO at Cellular Origins, at the ELRIG Drug Discovery 2024 conference to discuss how integrating proven tools and technologies, such as automation, helps cell therapy companies scale up production and ultimately make these life-saving therapies more accessible.
Blake Forman (BF):
Dan Strange, PhD (DS):
BF:
DS:
BF:
DS:
BF:
DS:
BF:
DS:
For those not familiar with your work, could you explain the broad aims of Cellular Origins technology?
Dan Strange, PhD (DS):
Our mission is to enable patient access to cell therapies, and we understand that to scale up manufacturing, we need to provide automation solutions to industrialize cell therapy. Automation is mentioned a lot in this industry, but we must consider what industrialization looks like. What does it mean to make these therapies when you're making not just thousands, but tens of thousands and hundreds of thousands a year? For us, we work together with key technology partners to provide full robotic automation, linking together an ecosystem of proven tools and technologies. This will enable therapy companies to change gears when they need to scale up without having to adjust their processes.
BF:
How does your technology stand to impact cell therapy manufacturing?
DS:
We’ve been working on cell therapy technology for a long time, and this is a landmark year for cell therapies. If you go back to seven years ago when Kymriah (tisagenlecleucel) was approved, since then we've had a suite of new approvals and gradually the patient populations have climbed each year. Last year, approximately 10,000 patients were treated with approved therapies. This year, we've had the movement of Carvykti (ciltacabtagene autoleucell) and Abecma (idecabtagene vicleucel) from fifth-line treatments to second- and third-line treatments. We've had the first therapies from Iovance Biotherapeutics and Adaptimmune (ADAP) approved for solid tumors. There's also been Casgevy (exagamglogene autotemcel) for sickle cells. Now the need to scale cell therapies to hundreds of thousands of patients is no longer something that's around the corner. Right now, thousands of patients could benefit each year from the cell therapies that are already approved on the market. So, that's what we're aiming to provide – the step change from the manufacturing technologies and tools of now, that give that order of magnitude improvement and scale needed to reach all the patients out there.
BF:
How do you envision automation technologies contributing to sustainable industrial processes in cell therapy manufacturing?
DS:
If you look at the existing state-of-the-art manufacturing of cell therapies, they are incredibly capital, space and labor inefficient. There are public examples of facilities that are 19,000 square meters, have 900 employees and are effectively making 10 therapies a day, or 4000 therapies a year. With automation, you can add capacity at the rate-limiting steps and end up with a process that is substantially more space and capital-efficient. Taking the example of making 4000 therapies a year, with Cellular Origins technology we use fully-closed mobile robotics to industrialize cell therapy factories which can potentially be 30 times more space efficient, using 16x less labour. This means you can save around 1200 tons of CO2 each year just from that building saving, so you can be incredibly more capital and space-efficient, which drives down the overall energy need.
BF:
What advice would you give to a therapy developer looking to implement automation for the first time?
DS:
One of the key things is understanding when it is the right time to adopt automation, and what’s phase-appropriate. There's been a lot of recognition in the industry that, eventually, automation is something that will be needed. But, if you're a therapy developer, when you're in your early phase 1/phase 2 trials, nearly every dollar you spend is going to go into getting to that next step in the clinical trial. When you get to developing a process that gives you the best chance of improving drug efficacy and uses the best tools, only then does the need for automation and scale begin to come to the top of the priority list, but by then it's difficult to change. What we provide is a solution built upon existing technologies. This enables therapy developers to change gears at that point when they need automation and to do so with minimal change of process
BF:
What impact do you hope automation technologies will have on cell therapy manufacturing in the next two years?
DS:
This has been a landmark year for cell therapies and the need for these technologies is no longer a theoretical one, we need the technologies now and deployed in the next couple of years. Otherwise, we're going to have tens of thousands of patients who aren't getting the therapies that could be curative. That's what I hope our automation technologies and other automation technologies out there will do.
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