Name:
Effortless expansion: an interview with Jenny Stjernberg
Description:
Effortless expansion: an interview with Jenny Stjernberg
Thumbnail URL:
https://cadmoremediastorage.blob.core.windows.net/79737b24-58b0-486b-af5a-66080a31cc47/videoscrubberimages/Scrubber_9.jpg
Duration:
T00H08M48S
Embed URL:
https://stream.cadmore.media/player/79737b24-58b0-486b-af5a-66080a31cc47
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/79737b24-58b0-486b-af5a-66080a31cc47/ScaleReady Jenny Stjernberg Interview V3.mp4?sv=2019-02-02&sr=c&sig=skNsK38xifqX4eVniiUCq6IPIkpYZNU0LPf3DWazcQs%3D&st=2024-05-10T12%3A15%3A06Z&se=2024-05-10T14%3A20%3A06Z&sp=r
Upload Date:
2023-10-09T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Introduction.
Hi, my name is Jenny, I am the commercial director for ScaleReady here on the European side. ScaleReady is a joint venture, for those of you who don't know us, we have been around now for a little bit over three years in the cell and gene therapy space. We are working with partners that's got gold standard tools and technologies that are really powerhouse players in the industry. They came together as they realized that they're stronger off together, so they formed ScaleReady.
Segment:2 What challenges are associated with the scale-up of cell and gene therapies? .
The cell therapies have now been around for a decade. We had the first approved medicine in 2017 and from thereon we've had now seven approved drugs. We are still in the early phases, so we are still learning. The scale up part has been a challenge because how are we ensuring that we have capacity, that we are automating the right things at the right time? And there's been a lot of efforts into solving all these problems, all with a very good intention to get this quicker to market and faster to patients. However, some of them have been misguided by old concepts, by old technologies that we have automated complexities rather than to eliminate them. I wouldn't say that it set us back, but it made us have a lot of good learnings on how we can do. And how we can do this even better in the future. So the industry right now has taken a little bit of a step back to scale down the automation part, simplifying it to ensure that we are ready for the next wave of automation and automating the right thing so that we actually can scale up and scale out efficiently.
Segment:3 How can flexible manufacturing approaches address these challenges? .
For us, it's been very important to educate the field about the fact that you need to start thinking early about your end. What is your goal with your cell therapy? Are you intending to take your early research, through clinical manufacturing to, you know, eventually, if successful, to a commercial scale? If so, you need to start thinking already at the research bench on how are you going to scale this process now and onwards, ensuring that you're positioning yourself in a place where you can scale your manufacturing up to the first clinical trials, but also that you don't need to change so many parameters to scale out and scale up and out to your BLA's and your commercial manufacturing, ensuring that you have a platform where you can automate the right pieces at the right time, not doing everything from the start, but really having the ability to build and be flexible to add things along the way. But if you're going to be able to have that flexibility, you need to think about it to start with. And that's something we've heard, you know, multiple people talking about here at Phacilitate both in the morning sessions today as well as yesterday, the need of thinking about your full solution already on the research stage.
Segment:4 Why is it important to consider scaling-down in your manufacturing processes? .
Often we are thinking about the scaling up and the scaling out because it's the path forward, that's the way ahead, however, this is a long process. We are we're not going to go from research to commercialization in a couple of years or, you know, even not in one year or multiple. During that period of time there will be changes to every process. There may be reagents discontinued or other parts where you realize that there are new technologies that could help and simplify the process. If you don't have a scaled-down model, you can't go back to the research bench easily to change out the component, to go back to the drawing table and look at, you know, what is the side effect? Is this side effect due to myself? Is this side effect due to the components that I'm using? So having the ability to not change process from clinical to research is as important as from research to clinical. So ensuring that you always can balance between the two, because even though we're going into a clinical setting, we're not done. The developer needs to realize that they will, from time to time need to go back and identify additional information from their source.
Segment:5 How can simplifying your processes improve scale up?.
By making sure that you have a process that is simple, that is not building in complexities from the start. This way you don't also need to automate around your complexity. So if you have a very simple process, it will also then be very easy to automate this process. So ensuring that you're eliminating as many steps as you can along the way, working with your tools providers to really take away rather than to add complexities will be key, as in the end, we need to think about, you know, hands on time from operators. We need to think about cleaner space because, I mean, operator and cleaner space are two very big cost drivers for commercial manufacturing. So if we can decrease those portions and ensure that we can manufacture in a small space with the least amount of hands on time, this will be a way to also have a successful drug product on the market that will be sustainable for a long time.
Segment:6 Why is standardization such a buzzword for the cell and gene manufacturing industry? .
Yeah, there are so many ways of talking about standardization. So it's everything from the standardization within each therapy as well as the standardization as a whole. But if we look at the drug products that are out there today that are commercially available, we have for a very long time talked about the processes, the product. But when we look at all these processes, they are, I wouldn't say identical, but to 60-70% they are very they are identical, so they are very similar. If we can start collaborating and ensuring that and that we actually have processes that are standardized, we need to maintain flexibility in the standardization here because all cells will behave a little bit differently, but the process on the overarching scale will be the same. And this is what we have seen now after having, you know, this many approved medicines and so many, you know, it's 100 in the pipeline, they are also very similar when it comes to the process. So we can standardize the process as long as we are maintaining the flexibilities within it.
Segment:7 If there was one thing you could ask for to bring cell and gene therapies from the lab to the clinic faster, what would it be? .
I think we need the educational piece to the labs. Talking to several people this morning in the roundtable session, it's clear that there is a need to bring therapies from the academic setting all the way to commercialization. A lot of great research is happening today, academic centers are there, they are doing good things and they are publishing - that's their goal. However, if we could educate them into, you know, moving away from or educate the universities and the grant givers to actually give grants for the process optimization as the next step when they found their potential construct that they want to move forward with. If we can take that, we will be able to move more therapies to the market in a quicker way. I'm worried that we are today doing a lot of development, but we may not take it all the way. So if we could, you know, jointly move that, it will make an impact for the industry.