VIDEO: Manufacturing process a challenge for CAR-T

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That's a hugely important question, and I think the challenge here is that there's a manufacturing process. So unlike other off-the-shelf therapeutics or those that can be delivered from a pre-manufactured stockpile, and that's virtually every kind of pharmaceutical that we have available in the domain of oncology. CAR T-cells are very unique because they have to be manufactured, and that involves the process of pheresis, to collect the initial starting product or T cells with which you're gonna work, and then it would go off to the manufacturing facility. Delays can range over a matter of weeks, which for patients with very, very aggressive hematological malignancies may in fact be a rate-limiting step. What we've seen in the domain of care of people with lymphomas, for instance, is that that six to eight week manufacturing, QC, and turnaround period, for 20% of patients, it might lead to such a delay that their disease progresses and they're no longer eligible for therapy. So this is a real challenge, especially when you're looking at therapeutics that, again, in the lymphoma domain, we would be looking at patients as candidates for either hospice or CAR T-cells given, you know, the nature of how these were deployed initially. So looking at this in the myeloma space, what we're looking for is three things. One is for patients and referring clinicians to become more aware earlier on that this is an option. Because the earlier you can refer patients so that they can be assessed for candidacy, the less likely that you're having to do things in a rush, rush, rush situation. The second thing is you need to build up robust programs. Because these cells need to be delivered within the context of a program which is designed to deliver them effectively, efficiently, and can effectively screen patients quickly analyze, allocate, adjudicate who's the right person to move forward, and then move forward quickly with manufacturing. So when I look at what's been done at City of Hope on the myeloma side in terms of the disease team organizing in alignment with the apheresis portion of our organization as well as the CAR T-cell quality review committee, that's the committee that would look at to see whether or not patients are really appropriate candidates for therapy. That system has to be in place and highly robust for this to work effectively. So, you know, we've been working on this most certainly at our institution. The other portion is that as manufacturers see that the number of patients grow who have a need for this, they will also need to scale up their manufacturing facilities. And we've seen this happen within the lymphoma space in the past.