The manufacturing burden is real, but a large share of it is a people problem wearing a process costume. For an ATMP the product is effectively the process, so every comparability question, every site transfer and every batch deviation lands on a very small group of people who have actually done it before. That scarcity is what makes the cost curve so stubborn. You can automate a fill line; you cannot automate the judgement needed to argue comparability after a change, and the people who can do that are already spoken for. Which is why tech transfer capability, not equipment, is usually the binding constraint on a cell and gene programme. Background on what an ATMP actually is and why it is regulated differently: https://www.sire-search.com/wat-is-een-atmp-advanced-therapy-medicinal-product/
This is the unglamorous truth nobody wants to lead with: the science works and the manufacturing line is where it dies. A therapy that cures one patient in a trial but cannot be made reproducibly at scale is barely a therapy. Do you think the fix is mostly regulatory, or do we need genuinely new manufacturing platforms before these cures become routine?
It's easy to fall in love with the latest shiny rock. We will look back and wonder why we missed the greatest event which was the Monk's knowledge Renaissance that is going to change absolutely every aspect of everything in our lives and make AI look insignificant by comparison. Explaining chemistry so that we can understand things like batteries or what's going on around us or empowering us to take on things like Climate Change is stupendous real progress, not a toy. AI is more like looking in the mirror while the monks balance of forces that gives us The Theory of Everything will actually cause a tsunami of progress that will transform us from a caterpillar into a butterfly. I probably the biggest field affected will be biochemistry!
The URL in this sentence is not working: "The white paper that followed recognised the structural dysfunction, but offered little in the way of a practical solution." However, I was able to find the paper here https://www.asgct.org/advocacy/policy-statements/addressing-potency-assay-related-development-delays-for-cell-and-gene-therapies-results-of-a-scientific-exchange-between-fda-and-developers
Thank you for pointing this out. Will replace
Is there any chance of running such a lab in the EU? Or are the rules as bad?
The manufacturing burden is real, but a large share of it is a people problem wearing a process costume. For an ATMP the product is effectively the process, so every comparability question, every site transfer and every batch deviation lands on a very small group of people who have actually done it before. That scarcity is what makes the cost curve so stubborn. You can automate a fill line; you cannot automate the judgement needed to argue comparability after a change, and the people who can do that are already spoken for. Which is why tech transfer capability, not equipment, is usually the binding constraint on a cell and gene programme. Background on what an ATMP actually is and why it is regulated differently: https://www.sire-search.com/wat-is-een-atmp-advanced-therapy-medicinal-product/
This is the unglamorous truth nobody wants to lead with: the science works and the manufacturing line is where it dies. A therapy that cures one patient in a trial but cannot be made reproducibly at scale is barely a therapy. Do you think the fix is mostly regulatory, or do we need genuinely new manufacturing platforms before these cures become routine?
Did you read the part about the batches working just as well, which were out of specification?
It's easy to fall in love with the latest shiny rock. We will look back and wonder why we missed the greatest event which was the Monk's knowledge Renaissance that is going to change absolutely every aspect of everything in our lives and make AI look insignificant by comparison. Explaining chemistry so that we can understand things like batteries or what's going on around us or empowering us to take on things like Climate Change is stupendous real progress, not a toy. AI is more like looking in the mirror while the monks balance of forces that gives us The Theory of Everything will actually cause a tsunami of progress that will transform us from a caterpillar into a butterfly. I probably the biggest field affected will be biochemistry!