Maxime Feyeux: How much money and time is needed to automate a process? What are the key factors impacting the development time and overall expenditure?
Jon Ellis: It’s not going to surprise you to hear me say “it depends”. The real “it depends” comes from how much development you need to do. If you utilize existing technologies, that are used and are proven, it may be an integration exercise. That’s a bit more straightforward than having to develop new technologies, which has an unknown timeline.
There are pros and cons against different approaches. So, off-the- shelf technologies can be arranged in series as part of the production process. We know what they do, those platforms have been around for a number of years. But they’re very limited in terms of scalability, how to use lots of different single-use sets from different platforms and integrate them together.
We know a fully automated system may take longer to develop and be more costly. But ultimately, you can design that around your process, and so you can look at the cost of goods (COGs) and the process efficiency and drive down costs later on.
The ideal model is a hybrid model, where you have technologies you use now, potentially, off-the-shelf, at individual operation level, but then ideally be able to use those same tools in a fully automated system further down the line.
I think one of the things that needs to be considered as well are the ancillary processes such as media or viral vector preparation – people maybe don’t consider those as much. It’s fine to blend media under a hood for one, two, three patients, but, if you start treating in the autologous space, making doses for hundreds, thousands or tens of thousands of patients per year ultimately it becomes a much greater challenge. So automation around some of the ancillary processes can really help drive down your operator costs as well.
Finally, the thing that impacts the cost is scalability. In the allogeneic space for example, how big is a batch. So maybe upstream, you can make a dose for a thousand patients, but can all the rest of your process steps align with that? For example, after your culture phase, you have enough cells for a thousand doses – can you actually formulate and freeze a thousand doses at the same time? It’s a pretty complex scenario for some people, but I think the key to keeping costs and timeline to minimum, again, is really just making sure you understand your requirements.
Maxime Feyeux: Could you give a rough timeframe for a more straightforward automation case study?
Jon Ellis: Relatively straightforward automation steps may take somewhere in the order of 12 months if it’s a case of limited development and aligning off-the-shelf technologies and not a huge integration into manufacturing execution systems. But beyond that, it really can vary quite significantly, depending on the scope.
Maxime Feyeux: And a rough cost for the same thing?
Jon Ellis: There are too many variables to give a baseline cost. With any new project one of the first things we do is to develop the business case and the projected timelines and costs to be upfront about what’s needed so as clients embark on this journey, they have very clear expectations around what it’s going to take.
But I don’t think there’s a “here’s what it would cost approximately” – as it really depends on the individual use case. Things to evaluate include: Is there any technology development required? What is the scope? What kind of scale is needed? Will operations be in multiple jurisdictions? These factors impact the timeline and cost quite significantly.