Out of curiosity why is engineering live cells at scale impossible? Is it because there is a huge probability that things will go wrong? Is it logistically and technically more difficult than manufacturing say a microprocessor?
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?
I don't think it's impossible, it's just really hard. I have no experience with microprocessor manufacturing so can't really speak to that. I also dont have experience in the lab but have provided operations / admin support to cell therapy manufacturing processes
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.
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?