Counting The Steps To Decentralized Personalized Therapy Manufacturing
A conversation with Judy Chou, Ph.D., AltruBio
On-site manufacturing for personalized therapies remains elusive for most companies. Infrastructure is lacking and, at a foundational level, there’s disagreement over how to solve the pressing challenge of logistics and accessibility for drugs that use patients’ own cells as starting materials.
Many drug manufacturers, healthcare providers, and patients see the potential benefits of producing autologous therapies at the point of care (POC). However, even among its proponents, there is less agreement on the best path forward, says AltruBio CEO Judy Chou, Ph.D.
Chou is an outspoken advocate of decentralized manufacturing for cell therapy and of taking a methodical and incremental approach to get there, one that will likely take more than a decade to fully realize.
Beyond on-site manufacturing for personalized medicine like autologous cell therapy, there’s a nascent interest in developing decentralized manufacturing for other drugs like antibodies.
We had questions about her perspectives on POC manufacturing for autologous therapy and other modalities. Here’s what she told us. Her answers have been edited for clarity.
During an ISPE conference presentation you gave back in 2023, you talked about the fractious perspectives around POC manufacturing and whether the industry is ready to move in that direction. In your opinion, has the mood changed at all?
In my point of view, and I have a strong opinion about that, I feel autologous therapies in particular should be manufactured at the point of care. There are different opinions, but even when you zoom into autologous cell therapy, particularly CAR-T, can we immediately go to POC? I don’t think so.
During my talk, I said it will probably take seven to 11 years with important steps along the way. It must start with the semi-manual or semi-automatic, depending on how you look at it, into the second step, which is fully automated manufacturing. The third step is the modularization of GMP. Then, ultimately, you reach the POC.
If you ask me, I think the investment into automation, toward modularized GMP, needs to happen. If I were in that business — and currently AltruBio is not — I have to humbly say that I would invest to make it happen. What worries me today, two years from the ISPE conference, is that few companies are investing in the steps.
Most people want to immediately get to point of care, but we run into issues without the automatic processing and without modularized GMP units.
We don’t want POC so we can be fancy or to let hospitals and academic institutions do it by themselves. It’s really for the benefit of patients.
For personalized, autologous cell therapies, point of care manufacturing makes sense. What's the case for hospital-based or modular manufacturing for antibodies or other drugs where economies of scale might be more obvious?
For antibodies, other protein therapeutics, or even small molecules, it’s less about personalized medicine; it’s more about being able to benefit the majority of the population of patients. I think centralized production makes more sense here.
When I used to run a big pharma organization, people would say, “It’s just because you want to make more money.” But objectively, I think it’s the right thing to do. There’s a lot to manage — consistency, GMP, the regulations — if we break that down and decentralize, it’s just going to introduce a lot of costs.
For any commodities, if we can centralize and make them more industrialized, we should do that.
Let me clarify: the reason I really support cell therapy POC manufacturing, particularly for autologous cell therapy, is that you need to get a sample from the patient, process it, and then deliver it back to the patient. That’s why you can fully realize the value of being onsite.
I think for other modalities, if we can centralize and make it more efficient and bring down costs, I think that’s the right thing to do.
You have described the need for a reliable supply chain simulation. Can you describe any progress you've seen on that front? Have you attempted to model the supply chain at AltruBio? What would that even look like at a global scale?
I see the entire field moving toward that. This is the bigger picture connecting research, clinical development, and manufacturing. The starting point is collecting information from the patient.
In early development, commercial manufacturing seems far away, but it’s really connected. We found patient feedback about taking the drug will actually inform a better forecast of the market and manufacturing.
Usually, the biggest increase in the cost of goods is because you don’t have a reliable forecast. On the manufacturing side, companies spend a lot of time improving on the process itself, which absolutely needs to be done. But in the grand scheme — this is frustrating — it really doesn’t change too much.
The biggest questions are: How many batches? Can you provide just-in-time manufacturing? Can you model the whole supply chain? I think we’re building elements of this.
At AltruBio, we are trying to introduce as many tools as possible for the patient. For us, it’s not too difficult to predict the manufacturing batch. We are again, humbly, a small company, so we can have this information on how many lots to produce going into manufacturing.
So, if we can, let’s zoom into a drug we are currently working on for ulcerative colitis (UC). One of the important endpoints is endoscope improvement. Patients already suffer so much pain with UC and/or other immunological and inflammatory disease, and they need to manage that every day. Endoscopy is tough even for any healthy person.
We think hard about how technology can be used less painfully, less invasively, and how the drug can be used most effectively.
I think, ultimately, for all drug developers, to start thinking about how these things from the research side, the clinical side, and manufacturing, all connect together, we can be much more efficient and sustainable and much more quickly introduce medicines for patients.
About The Expert:
Judy Chou, Ph.D., is CEO and president of AltruBio. Previously, she was senior vice president at several companies, including Tanvex, Medivation, and Pfizer. Before AltruBio, she was senior vice president and global head of biotech at Bayer. She received her Ph.D. from Yale and completed postdoctoral training at Max Planck Institute and was a research faculty member at Harvard Medical School.