The challenges of commercial-scale ATMP production
The crux of the problem is that in the clinical phase, where many ATMP companies are today, the goal is investigation and discovery. You want and need flexibility, so the process is open and operator driven. But those enabling factors at small scale will limit you as you scale out.
If the process stays operator-driven, it will require a facility that can accommodate a significant increase in personnel—and that doesn’t just apply to the labs/manufacturing spaces; it’s the breakrooms, meeting spaces, parking lots, etc. The facility footprint and the cost grow exponentially.
Additionally, if the process stays open, it further increases your cost while limiting your functionality and productivity. You’re looking at multiple clean rooms with transitional airlocking space and QC labs, which are costly to construct and maintain. And the process of moving products through the spaces becomes cumbersome.
Ideally, you overcome many of these challenges by shifting from an open, operator-centric process to closed and automated. Of course, where that’s not possible, pre-planning can smooth the path for you down the road. If you have ingenuity, time (because you started planning early) and these five considerations, you will be prepared to successfully scale up your ATMP production when that eventuality comes.