Total quality recognizes that for best cell potency, cells need full-time optimization of all critical cell process parameters, during incubation, and also during handling and processing upstream and downstream of incubation.
Total quality recognizes that all typical negative side effects of machines on cells (particles, heat, vibration, etc.) must be neutralized to make automation compatible with a cell optimized ecosystem.
Total quality recognizes that each batch must have a complete end-to-end secure batch record of all critical process parameters and all critical environmental parameters.
Total quality recognizes that unlimited numbers of batches must be producible simultaneously side-by-side (massively parallel) with 0% cross contamination risk and dispersed globally with 0% variance risk and evidence to prove it.
Total quality recognizes that scaling up and out must be efficient with 0% variance risk and evidence to prove it.
Total quality recognizes that validation of new production capacity regardless of scale or location must be 100% reliable and fast (within days) and quick and easy to move, to different locations globally or locally as needed (within weeks).