Designing commercial ATMP facilities and processes

Peter Walters, Advanced Therapy Medicinal Product Subject Matter Expert and Kim Nelson, Senior Director, Strategic Consulting, at CRB were interviewed by Cell and Gene Therapy Insights on “Designing Facilities and Processes with Commercialization in Mind.”

Below is a snippet from the interview:

What is your vision for the commercial cell and gene therapy facilities of the future in light of the directions in which you see the sector moving today?

Peter: In terms of cell therapy, I certainly expect to see a continuation towards process closure, and increased adoption of new technologies that are not only closed but also automated, to help reduce the requirement for skilled, trained operators. We will see increased availability of inline monitoring, providing valuable data so that processes can be adjusted in real time. This will be vital given the variability in quantity and quality of the starting materials for some of these cell therapies – it will allow for a process that is adaptable to those varying conditions.

As I touched on earlier, I believe we will see processing systems that are able to be integrated vertically, so as you look towards commercial manufacturing for much larger patient populations, you will be able to maximize the number of patient treatments per square footage of your facility, without the need to grow your facility a great deal.

And then as Kim mentioned, we’ll see not just the automation of manufacturing process but also of QC testing, and maybe even automation of portions of the warehousing, because the number of materials is going to be immense for all the individual products and processes.

Kim: What I see coming is really a higher level of automation, but that automation is not going to solely take the form of a robot or a machine. I think we’re probably going to see more of a cooperative operator-robotic system that’s sometimes been called ‘cobotics’.

It leverages the strengths of the operator in their flexibility and adaptability to respond to changing conditions, while utilizing the strengths of the robotic system for repetitive movement; a robotic system is very amenable to transport insertion and removal of items, whereas an operator is much better at doing connections. To have a robotic system make tubing connections is not really very doable at this point, so it would require a reworking of the designs of these systems. That can be done, but whether or not that’s going to be the most efficient way to do things remains to be seen.

But I think when you look at automation, what we have to keep in mind is that sometimes perfect is the enemy of good. In terms of getting a product onto the market and producing it at a reasonable manufacturing cost, automating something may not actually be the answer – it could even conceivably raise manufacturing cost, if it was over-automated.

Read the full interview here.