The T-Cell treatments or CAR-T cell treatments is one of the most promising lines of research in cancer treatment. Fred Hutch is doing a lot of research on right now. Seattle Cancer Care (which is associated with Fred Hutch) has an entire floor devoted to CAR-T trials. https://www.seattletimes.com/pacific-nw-magazine/the-hutch-i...
The interesting bit is that this is a successful trial on a solid tumors. CAR-T has shown that its most effective on non-solid tumors or blood based cancers. A few months ago there was a Stanford press release on them doing a combination of injecting solid tumor CAR-T and alcohol, which caused a singular tumor to be attacked and removed.
The manufacturing process is logistically and technically very difficult. You are engineering live cells, an extremely complex and delicate "process". Things that shouldn't affect product quality for simpler drugs like proteins end up totally changing the biologic function of the product
There's been effort to automate this but it's been difficult. Innovation here would be incredibly valuable
Almost everything we do these days is automated to some degree at some point. Is it mostly a question of large sums of capital to develop the tooling necessary?
Part of the challenge is just that live cells are complex living things. They interact with their environment in difficult to predict ways. You can only measure so many cell characteristics at a time, certainly not enough to get a full picture of everything that's going on, which makes in-process quality testing very difficult. A manufacturer we worked with said "process is product", which means we dont know how to measure product quality that well so we have to basically reinvent the process every time it changes. I think getting the right tooling to measure quality would help but that would require some really breakthrough innovation.
Another challenge is shelf life. You need to get these cells to patients quickly once they leave the lab, often requiring climate controlled air shipment if the patient is far from the lab. And you dont want to build too many labs, as transferring a process from one lab to another is very expensive and fickle.
The process of selecting cells to engineer is pretty complicated and labor intensive. Basically you have to get a patient to a clinic, draw blood (or biopsy), process the sample for shipment, ship it to a lab (often have just a few hours to get this done), then you do a number of steps to isolate the specific cell types you want. A lot of this is manual but isn't really novel, the techniques are pretty well established and straightforward, some probably could be automated but im not sure how much, and it would be expensive to automate. I think a few large manufacturers probably invest heavily in automation but most small companies or academic labs probably cant afford it
The process itself is extremely difficult with lots of ways that it can go wrong. But as with other areas of molecular biology, there's hope that the consistency of automation may improve that.
Current cancer treatments that are used in practice can easily make it in to tens of thousands per month of treatment. That provides a lot of wiggle room for doing expensive things.
Once there's a reason to produce thousands or millions of individualized cell therapies, it's likely that the process could be made economically feasible.
The article has a few good cautious warning, in particular:
> But experts caution that the treatment has only proved itself in one woman and that the clinical trials are needed to see how effective the therapy could be in other cancer patients.
Too good short explanations in comic forms are: