If your process relies on the "golden hands" of a specific scientist, you don't have a product, you have a research project. Nicholas Crudele and Arnaud Deladeriere discuss the critical leap from academic science to GMP manufacturing in cell and gene therapy.
We cover:
What is CMC? (A primer for founders) .
Why the "Product is the Process" mindset fails in cell therapy.
How to use "process parameters" as dials to control patient variability.
Why you should use GMP materials as early as possible.
