Schutte continued, “Instead of redeveloping the process and undergoing the risk of having to change our process significantly between Phase III and commercial, we were able to develop a platform where we could scale out and have minimal change in the process where we can increase the batch size to add to our production capacity. Automation was certainly a part of some of that, single use technologies were certainly a part of that.”
Ronfard shared how CUTISS has been able to develop their process, “Firstly, we are in the autologous business, so we are producing a limited quantity of bioengineered skin. The first thing that we needed to consider was between automation and robots, and robots are not suitable for this type of business model because the segregation is more difficult.”
He continued, “With automation, we had two choices; do we want to go for the fully integrated machine or do we want to go with a modular approach where we can go step-by-step and also, not only develop our own modular automation, but add some modules that are already available on the market. We went with the modular approach and now we are able to have an inline process with different modules.“