Watch the 10 minute interview with Magnus Schroeder, VP Process and Product Design at Just - Evotec Biologics, at Biomanufacturing World Summit 2024. For a complete table of content regarding Magnus’ discussion, please see below.

• 00:00 – 00:35 min Intro
• 00:36 – 02:44 min First-in-Human projects
• 02:45 – 04:27 min How we partner on projects
• 04:28 – 06:12 min Our approach: Using continuous manufacturing to maximize quality while accomplishing high productivity and lower production cost
• 06:13 – 07:40 Cell Line Development: Our new J.CHO® High Expression System combines extremely high titers with the best product quality
• 07:41 – 08:31 New biomanufacturing facility in Toulouse, France
• 08:32 – 09:34 Partnering with clients on antibody

Geoff: Hello again, everyone. You're joining us for another episode of Executive Platforms' Blueprint podcast series. My name is Geoff Micks. I'm head of content and research. My guest today is Magnus Schroeder of Just - Evotec Biologics. We're going to be having a conversation about continuous manufacturing in the biopharmaceutical space, with a particular focus, I think, on first-in-human, which I think is a really exciting topic. I think it's something that there's a lot of good information to be gained. Magnus, thank you so much for joining me today.

Magnus: Thanks for having me.

Geoff: Why don't we start off with some of the questions pharmaceutical manufacturers should be asking themselves when they're talking about their first-in-human programs, when they're seeking partners to help them get there. What are some of the conversations you have with your clients in this space?

Magnus: Yeah, it's a really great topic because, of course, it's the start of a very important journey for our clients to really bring their molecules to the clinic and really test out whether the molecule works for patients and is safe. So, what we can really bring to them is a reliable partner that works with them towards their goal of manufacturing clinical material in a very competitive timeline and also provide them with the right set of technical and regulatory support to get them to their final goal of actually getting an IND filed and then really start their clinical work.

Geoff: So, I can imagine it’s a very exciting time when a pharmaceutical company is getting to that stage. What are some of the things that they should be keeping in mind as they weigh the pros and cons of different partners?

Magnus: Of course, you really have to work with a partner that can help you as a client. I've been on the other side myself working with CDMOs on achieving those goals. I very much know exactly that you have a lot of topics that you have to cover on your journey. So, we as Just – Evotec Biologics can bring a lot to the table on what we would call the CMC side of things of manufacturing and releasing drug substance for clients. And the things that you really want to have is that you cover all your bases, that you have a reliable source for your cell line, that you have a stable productive process which also delivers on phase-appropriate specifications. Ultimately, of course, also that it's done in a very compliant way which we will bring also with a very commercial quality system and also deliver, in our case, really outstanding performance of the process of delivering highest quality of protein drug products with a very high titer.

Geoff: I wonder if we could get a little bit into the cultural fit of it all because I think when a company is getting to that stage where they're ready to partner with a CDMO, what they're really getting is a lot of experts on their team all at once but they want to make sure this is going to be a good fit for quality culture, for how we deal with data, for that we are entrusting you with the next stage of our project and obviously they're coming with the thing that they've been working on for years. You are helping them take the next steps with it. Walk us through some of that culture and making it a good fit.

Magnus: Yes, absolutely great question because many of our team members have actually also worked on the other side and have entrusted programs to other CDMOs. Many of us know very well that this is an important partnership to bring a program forward. We recognize, of course, that our clients know a lot about their molecule and what they want to do in the clinic, and we completely recognize that value. We ask the right questions to understand what can we do on the CMC side to help them achieve their goals, but we also see us as a great partner that takes over the part that we can do best on the technical and CMC side clearly recognizing that sometimes programs also need to pivot just because biology can be complex so when news comes in that the molecule may be doing something differently then we fully understand we may have to change certain things. Then what our partners, our clients, they get, of course, world-class quality systems, data integrity. That's generally highly important for us to ensure anyway that we have full data traceability and are compliant in every aspect.

Geoff: I had the pleasure of speaking with one of your colleagues last year and not to repeat that great conversation but I was fascinated with the idea that there is expertise even in the idea of controlling costs because of course what these people are experts at is getting their product to the point that they can partner with a CDMO but the idea of, you know, batch manufacturing versus continuous manufacturing, there are options to help keep things in a reasonable cost in an expensive world. Could we talk a little bit about that?

Magnus: It's a great question because Just - Evotec Biologics was specifically founded to really use technology to provide better access to biologics, which in our case really was to use advanced technology to use continuous manufacturing both in the bioreactor as well as in the purification stream to really drastically lower the cost of goods to actually provide better access to these biologics because they are expensive and not everyone may be able to benefit from it. So yes, we use this technology, and we actively use it and it really brings something wonderful to the clients really to be able to make highest quality product in a much smaller footprint facility but with much higher yields that you would normally get from a conventional fed-batch process. So, it's sort of a win-win. I would say that you don't have to compromise anything on the quality side and the timeline side of things but you just get more product and also later on it is much easier to then move forward into a commercial space using that technology because it takes away kind of the conventional scale-up challenges of finding large facilities and scaling up into large volume bioreactors.

Geoff: I appreciate it's the two of us sitting here having a conversation in a studio right now but you're at the start of an event where you're going to be having a number of conversations with technical operations people in the biopharmaceutical space. Is there something that you're really excited to share with them?

Magnus: Yeah, I mean it's really great that we bring this continuous manufacturing technology to our clients that they can really benefit from the investments that we made over the years to bring continuous upstream and downstream processing to recombinant protein manufacturing. I think what's really exciting is that it all of course starts with the cell line and we've also developed our own CHO cell line system that's of course the foundation or one of the foundations for our platform technologies. So that's really something exciting that we now have our own cell line using the latest genetic vector systems and you know highly productive proprietary media that is available to clients as well. So, I think that's worth mentioning that it's really there. The good thing is also because it's our own technology we can also slightly alter the cell line to address certain particular product quality challenges that some clients may face. So that's also an interesting opportunity to work with us. Come to us if you have specific product quality challenges that may sometimes be hard to address with conventional process development optimization alone.

Geoff: And I understand you’ve also recently expanded your footprint. Maybe we could talk a little bit about where you do business.

Magnus: Yeah I mean the whole story started in in Seattle but now we're really proud to say that we have both a site in in Seattle near the downtown area as well as a little bit further out of Seattle downtown in the Redmond area where we have a commercial sized facility that uses our innovative production technologies that can bring almost two and a half annual tons to clients. And we've now recently opened up a second facility that's a carbon copy of the Redmond facility in Toulouse, France. So really offers now clients both a US and a European footprint to manufacture their drugs.

Geoff: Fantastic. I know we've covered a lot of ground in this conversation. If there were a couple of things that you wanted to highlight for people have them think about a little further, what would you want to underline for them?

Magnus: I think it's really important for our clients to understand that they can come to us with their ideas of molecules. We may even be able to help them earlier to modify their proteins and express variants and pick the one that’s in the most manufacturable as well. So that's an offering that we have to our clients before we even start working on their on their programs. Then we really have very competitive offerings to bring first-in-human programs to the clinic in in one of the most modern facilities worldwide. But also once the molecule shows really its benefit in the clinic then we are also a trusted partner to them very quickly pivot the program to make ready for commercial commercialization activities as well.

Geoff: I think anybody who has been listening to this and is in the position of looking for a CDMO partner probably has some questions of their own at this point. For people who want to learn more what is the best way to get in touch?

Magnus: Yeah, it's a great question, of course. So, you can reach us on our website at evotec.com as well as on social media like LinkedIn.

Geoff: So, well I appreciate you giving a couple of different ways to get in touch. I have had the pleasure of speaking with both you and your colleagues over the years. I think you have a great organization that is doing a lot to advance the future of medicine. Magnus thank you so much for your time today.

Magnus: Thank you so much, Geoff, for the opportunity.

Geoff: You've been listening to another episode of Executive Platform's Blueprint podcast series. I've been Geoff Micks. Let's do it again soon.