Leading up to the Phacilitate Advanced Therapies Europe conference, David Hodl, Head of Business Development, Cell Therapy was interviewed by Phacilitate. The interview covered some of the current challenges the cell therapy industry is facing, what some of the different solutions and systems being adopted look like and the future of cell therapy manufacturing. David also introduced our recently launched Korus™ counterflow centrifugation system.
During the interview, David discussed:
The different solutions and systems being adopted to optimize cell-based therapy manufacturing and take development from the lab to commercial scale
Some of the challenges cell therapy developers are facing, including the variability of incoming starting materials, issues surrounding affordability and patient accessibility
The importance of standardization across the industry
The Korus system’s applications and features.
Watch the full interview:
Can you please introduce yourself and describe your role at Invetech
I’m David Hodl, the Head of Business Development for the cell therapy team at Invetech, and I’ve been with Invetech for four and a half years. Invetech is a company that provides solutions and systems for cell-based manufacturing to biopharma and biotech companies that are interested in taking their manufacturing process from a laboratory benchtop size manufacturing to scalable commercial manufacturing.
We are really excited to be at the Advanced Therapies Europe meeting in London. This is one of the marquee conferences that we go to every year, and we’re excited to be able to present data on our Korus™ system that we just recently introduced. We’re very happy to be in London with the rest of the cell therapy community.
What are the main challenges in cell therapy manufacturing?
We see some of the main challenges facing the cell therapy manufacturing space right now as: Firstly, handling the variability of the incoming starting materials. Because you’re working with biological material and inherently, there is going to be differences from patient to patient, from sample to sample, and that really provides some challenges to the manufacturing process.
We also see the question of affordability being one that is being considered earlier on in the manufacturing process. Not only the affordability of how much is it going to cost to manufacture and the kind of resources that we need, but also how that translates to affordability for the patients and accessibility for the patients. One of the other critical things that we see is the need and the request for standardization – and that can be in both the data perspective but also in connectivity between disparate unit operations.
How have cell therapy manufacturing needs changed? What solutions are essential for meeting these pain points?
As the manufacturing space has evolved, one of the things that we’ve seen is the evolution of manufacturing from the open manual processes that came out of the originators, the academics, that have developed the therapy and developed the first manufacturing process. Transferring that to industrial partners or commercial partners – that’s always a challenge.
The evolution that we’ve seen is going from a manual process to run the introduction of some automated unit operations, but also automated all-in-one manufacturing equipment. So, a sample in, and it does its thing, and sample out at the end and you have your therapeutic. And that’s great for some specific processes and therapies, but it doesn’t allow for a lot of flexibility.
One of the things that we’re seeing is a move towards wanting and needing flexible modular solutions for unit operations. Where those modules could potentially be not only used for one specific manufacturing process, but also could be shared by multiple manufacturing processes. That’s a really interesting evolution that we’ve seen. That is something that is progressing. We think we’re going to be seeing that for the foreseeable future, not only in autologous manufacturing but also potentially in the allogeneic therapy space.
We have seen many approvals in the autologous cell therapy space in recent years. Do you think these successes are to be replicated in the allogeneic space?
We think that we will see successes in the allogeneic therapy space. That’s a space that is actually moving from a clinical development perspective a little bit slower than I think the industry anticipated. We do see a lot of early-stage clinical development activity there, and that’s fantastic.
On the other side, we still believe there are autonomous therapies that are going to stay around, they’re not going to be wiped out. Primarily, because they’re efficacious of certain types of cancer, essentially, in some cases, I’ll use the word, curative. But they’re showing a very durable response, which is fantastic, and I don’t think we, as an industry, could take that away from patients. So that’s going to be here to stay. I think the question around allogeneic is being able to show consistent efficacy, which we’re beginning to see, and durable response as well. As we start to see that, then we tackle the manufacturing challenges as well.
How do you see the future of cell therapy manufacturing progressing?
We see the future of cell therapy manufacturing as a continuous evolution from those open manual processes that are done with a lot of people under hoods through closed integrated manufacturing systems. And now we’re beginning to see that ‘2.0 wave’ of manufacturing where companies are taking their manufacturing process and really optimizing it.
We see the shortening of the manufacturing process from essentially right now anywhere from 10 to 14 days for a CAR-T process, down to potentially 24 to 48 hours. And that’s using new technology that has been developed and began to be integrated in at least the process development phase, over the ‘1.0 period’, that first period of cell therapy manufacturing.
The successes there really are almost a precursor to what manufacturers and what therapeutic companies are looking at as far as potentially going into the point of care systems. That’s where you’re able to actually manufacture the product itself in a hospital setting where the patient could have their blood drawn or an apheresis done and then they manufacture the product there and infuse the patient while they’re still in the hospital. There are a lot of challenges to that that still need to be overcome, from testing capabilities all the way to actually making sure that you can maintain GMP in that environment. But I think we’re progressing toward that.
We’re excited you’ll be sharing performance data of your newly launched Korus system at Advanced Therapies Europe. Can you give us a short introduction to the system?
Korus is a counterflow centrifuge-based elutriation platform that can be used for isolating target cell populations from starting materials. In a lot of cases right now it’s apheresis. It can also be used for a cell wash media exchange or wash concentrate harvest unit operation within a manufacturing process.
We’re going to be talking about some of the initial performance data that we developed during the testing phase of Korus development, primarily around elutriation of lymphocytes, but we may also be talking about data around our washing capabilities, and really going through what the basic capabilities of the system are and how that impacts the efficiency of clients’ manufacturing processes.
I think the critical thing that we’re all looking forward to is being able to get together face-to-face as a community. I can say at the Phacilitate conference in Miami, earlier in the year, there was a great sense of community, when everyone got together and the spontaneous discussions, the sense of energy in the conference area, in the exhibit hall, was fantastic.
I think that provides for us as a supplier and a partner in the community a lot of opportunity to collaborate and provide some exposure to solutions that we have that may benefit our clients that they may not know about. It’s just fantastic to be able to get together and have those discussions and have a bit of spontaneity around meeting people that you haven’t seen in two or three years. So, we are very much looking forward to attending Phacilitate.
The Korus system is for research, laboratory or further manufacturing use only. It is not intended as a medical device in therapeutic or diagnostic procedures. Customers are responsible for validating the use of Korus within their process or therapy. Consult all instructions, terms and warnings prior to use of the solutions and products. Failure to do so can result in damage or serious injury, including death. Ready-to-run turnkey systems may require minor configuration before sale and use depending on customer needs.
Korus™: Transforming T Cell Manufacturing via Elutriation
This study compares Korus elutriation vs conventional washing and the impact on downstream unit operations.