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Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join us as we explore the journey of modern medicines, ensuring every product reaches its full potential in safety, quality, and accessibility.
Announcer - 00:00:04:
Welcome to Life Science Solutions, the podcast presented by Kymanox, where we explore the challenges, innovations, and future of our industry. This episode is hosted by industry expert and Kymanox executive advisor, Mathias Romacker, who is thrilled to welcome an old colleague and friend, Hanns-Christian Mahler, CEO of Ten23 Health. Mathias and Hanns-Christian's professional journeys intersected back in 2017 at the PDA Universe conference in Vienna, where they co-chaired discussions on pre-filled syringes and injection devices. A lot has changed in the life sciences industry since then, and today they'll discuss those transformations, Hanns-Christian's journey to founding Ten23 Health, and how the company is reshaping the pharmaceutical and biotech industries, and some of the most pressing trends and challenges shaping the field today. Here's Mathias.
Mathias - 00:00:57:
Hanns-Christian, we know each other for quite a while. And I would say it really started, if you want, when we both were the co-chairs of the PDA Universe conference on prefilled syringes and injection devices. And I think if I recall it correctly, it was in Austria, Vienna in 2017. And now having the pandemic and everything, it feels like a lifetime ago. But I still wonder, I mean, if you go back a little bit in time, back in those days and obviously before you founded your company, what do you think stood out during those days?
Announcer - 00:01:39:
Well, it's great talking to you, Mathias, and I'm very happy to see you again. It's been a while. And it's an interesting reference because also the PDA Universe of Pre-Filled Syringes especially, I think, keeps coming back as a theme. You know, there was just the conference a few weeks slash month ago, basically, in Phoenix. So it feels, from a memory perspective, it feels a little bit like a family reunion. Also thinking of 2017, I think 2017 sounds like yesterday, which basically means that I'm an old guy. It's interesting also from the sense because I feel like things have evolved so much on the device side. But then again, also not at all, if you think about it. I think there's still a lot of topics that keep us busy from a device perspective. You know, for over a decade now. And so that it is an interesting memory because it also feels like we're still talking about some stuff that we talked about kind of yesterday. And Vienna was a great party, I remember that.
Mathias - 00:02:51:
It was a good location. I think we all enjoyed it. I think we had this... First evening in this kind of tower and overlooking Vienna and the Prater and I think people really, really enjoy it. And I think it's coming back this year. So it's going to be in October again in 2025. So it's a whopping eight years later. It's going to be back in Vienna. So, I mean, reflecting on 2017, but now moving to now, I mean, you kind of covered it somewhat, but what are the most significant changes you see across our industry, broad trends? And in a certain way, I mean, I would also assume that also kind of triggered your desire to do what you're actually doing now, because you really shifted gears, Hanns-Christian.
Announcer - 00:03:39:
I think when it comes to themes, I really think that devices and I would say functional containers, more focused on patient convenience, a shift towards subcutaneous administration. I mean, things that we talked about. 5, 10 years ago, I think are now starting to materialize. If you look at recent approvals, I mean, if you look at just last year's FDA approvals, there's quite an increasing trend of sub-Q products. Also, if you look at the biologics that were approved, et cetera. So it feels like the things materialized that we talked about maybe a decade ago, at the same time, it feels also like some of the... Challenges that were related, syringes and devices are still around. So my saddest moment was actually when I looked at 2024 approvals for SubQ products and you see still a lot of vials, used well, I was thinking well. Why? Because, I mean, there's so many device options that would be much more patient convenient. So I would say industry has come a long way. There's an evolution. We're still having a little bit of the same challenges that we discussed a while ago. And when you said I changed gears, I frankly don't feel like I ever changed gears because I've been working with several products. Since day one I started in industry. But obviously, I think I've been always enjoying to be on the learning curve from what I'm doing, you know, with formulation and filling and having more exposure in the device field. I mean, being a pharmacist is being a little bit, being a jack of all trades versus maybe being the expert in all the specific topics, I guess.
Mathias - 00:05:29:
Yeah, let me ask you this. I mean, obviously, we talked about the change and then maybe the non-change. I mean, one thing that strikes me a little bit as somebody who's watching the market is, if you would have asked me in 2017, fast forward to now, 2025, and you see all those kind of conversations we had about on-body injectors, you were really thinking that by now we would have seen like a dozen plus launches, successful launches. But instead, it's a bumpy ride, isn't it? It's interesting. What are actually your thoughts? I mean, what did you see back then maybe, but also where do you see it now and where do you see this going?
Announcer - 00:06:09:
Absolutely. I mean, if I would zoom back in time, being in 2017, I would have imagined 2025 of being completely dominated by device launches and syringes and not people really thinking of Vile a little bit more being a, let's say, clinical service dosage form, like a means to the end and not really a commercial product that will actually be still dominating the market. I think one element could be the bumpy ride that you say is continuing challenges. And the industry remains very scattered. So you need to work with a device partner and a packaging partner to the most part, a finish partner. Maybe your formulation development is taking place elsewhere. So I think that you have a lot of pieces to the puzzle and things may happen at the interface of these puzzles being technical challenges, communication challenges, etc. But I would also say that... Let's say pharmaceutical industry is not necessarily famous for being fast adopters and early adopters in a lot of the technology. So it probably also speaks to being concerned from, from maybe management teams and leadership teams when it comes about these technologies or being concerned about seeing, you know, some of the cocks that are, that are implied when you see, you know, devices are expensive. And I mean, we are not a device manufacturer, but that's where I would probably foresee that, that some of the considerations are there. Or I remember discussions when it's about supply chain, making changes to the supply chain, you basically, have people in your typical workflows, infusion shares being handled, et cetera. And then, you know, going a different route to a patient, then me- Requires basically being brave and making that change and driving that change forward. So I think that's another consideration in my view.
Mathias - 00:08:05:
Yeah, definitely. I mean, again, I also was specifically thinking about those large volume subcutaneous on body injectors where they're really the uptake. I mean, again, it's like you kind of talk at those conferences, what shall be. And then I'm just surprised. And you just had had some good points here why this is actually taking longer than we sometimes wish for.
Announcer - 00:08:28:
And there's a lot of anxiety too. I mean, we are talking to quite a bunch of startup companies and talking to them about sub-Q administration. And to the most part... Colleagues in clinical development still believe that you can only inject one milliliter subcutaneously. And that's where i think the discussion usually starts saying, oh, can you really do more than one, and you know, how much can you really inject? And that's why I think, it's I've been really grateful to see a lot of, um, also let's say recent publications, um, uh, pushing pushing the needle, um, I mean literally, into maybe, you know, being able to inject 10, maybe 20 milliliters subcutaneously, and even without permeation enhancers. And seeing that published in the public domain now is great because it takes away that urban clinical myth of what is doable and what is not doable with pharmaceutical products. I think it really speaks to, you know, a lot of people being scared to actually try that.
Mathias - 00:09:34:
Yeah, I can see it. But it's also kind of disruptors like you who will actually really drive this. But it always takes, interestingly enough, longer than we think it should. Let's kind of switch gears. I mean, I have this one personal question here. And as I mentioned before with the introduction, I mean, you're also a professor, which is like, I mean, we don't have that many in the industry. At least I'm not aware of it. So, I mean, if you could maybe share a little bit more about your journey and also how this ties into your work at Ten23 Health.
Announcer - 00:10:07:
Thank you, Mathias, for the question. Well, I did study pharmacy. I did make a PhD in toxicology. And then I changed gears to pharmaceutical sciences by joining Merck at that time and then worked at Roche and Lonza, moved to the CDMO space with that move to Lonza and then eventually started Ten23. Now, I was always in pharmacy school, I was always interested by asking a lot of questions. Like I learned from a textbook, even what is an injectable, like, what is an acceptable pH for injectables? And I learned from two textbooks and they had different ranges. So that was the first time I thought, I really need to challenge secondary literature and just don't believe everything that is written. And I was digging into the topic a little more. And then I thought, actually, none of the books were right and it depends. And there was no primary literature on that, which really stimulated me to really, you know, ask questions in pharmacy and then try to research it. So that was always that research gene, also in industry, that was basically motivating me to look at these with interns and master students that I had in the team and stuff. The eventual decision to even do this so-called habilitation thesis, which is a German like big PhD and a qualification for professorship. Was also interesting when I was at Merck at the time and my boss at the time said to me, I completed all the trainings that existed. I think I was 24 and I couldn't believe it and saying, no, I will not have completed my trainings. I'm 24. I got, you know, 40 years to go in industry. And it's hard to believe that I completed all the trainings that I could do. So because I still believe in lifelong learning. And then he said, well, there's nothing I can offer you. And so I thought, well, it's actually a good idea to actually take, you know, the qualification of yourself into your own hands. And just don't wait for someone to offer you courses and everything. So I thought, you know, running a professorship thesis is actually a good idea. And I also saw with a lot of friends in industry, there was always this continued reorganizations every two or three years in all major companies, which basically meant that half the stuff would be terminated or, you know, a certain degree of stuff would be terminated. So I also thought, I don't want to rely on and waiting for a termination and maybe a package to actually seal my fate. And I want to be in the position of being flexible and thinking about what I can do. So that was actually what led me to thinking about a habilitation and professorship thesis at the first place. So I'm still adjunct faculty to both Frankfurt University and Basel University. And I'm also over. Seeing, you know, to a certain degree, PhD students. We do have two PhD students right now also at Ten23 working here who then have basically, you know, work in adjunct setups with the Frankfurt University, respectively Basel. And I can support these PhD programs then accordingly. So, side note, our chief scientific officer, Andrea, is also a professor. She's a professor at Freiburg University. So, basically, we have a second person in Ten23 actually who's done a professorship. And I think it's a good thing also if you're working in industry to make sure you stay true to the science and technical core of things. And you've got to make sure that you follow the science and science will determine on where the products will actually go.
Mathias - 00:13:50:
Yeah, and I can see also it's probably great to really have you as somebody with industry experience. Getting in front of students and talking to them and giving them feedback, etc. Hanns-Christian, we just talked a bit about projections before, and you were just saying something like 40 years and stuff like that. So if I make a bold projection here, I said, you're not going to stop after 40 years. So we shall see, but I strongly doubt it.
Announcer - 00:14:19:
Yeah, I cannot see myself being in pension as well.
Mathias - 00:14:22:
Yeah, so in a certain way, I mean, now let's talk about Ten23, which I think is very exciting. And I mean, it's always amazing to see like friends from the industry really. Doing something new and great things and you have already grown so much. But how did that idea actually evolve? Was it like a single moment? Did you wake up in the morning and said, I'm starting a company? Or did it more like take shape over time?
Announcer - 00:14:50:
Yeah, it's actually a very interesting story because, I mean, I've always been interested in building things. So also when I, you know, for example, when I joined Roche and I joined a smaller team and the task was, you know, go build an organization around formulation development of biologics and then eventually, you know, moving more into biotech R&D on the Roche side at that point of time. And similarly as to when I joined Lonza, my task was, you know, go build a new business unit for serodrug products and second task, you know, go build a culture, a team culture that actually can help to rejuvenate and, you know, explore a little bit with, you know, modern management style. So I think the story of building organizations was kind of accompanying me throughout my professional journey. When I left Lonza, I was not very clear on what I would actually do. And I did have a more traditional job offer as well. I was then connected to our investors now at Ten23, at 3i, by a mutual friend who said, and he actually said to me saying, oh, you left Lonza, you actually have to start a company. And I was actually telling him saying, well, I'm not sure. I mean, I was around about, you know. Turning 50 as well, you know, starting a company at 50 is maybe not a... It's not the ideal time point in your life. It seems a little late. And I don't want to run around bootstrap and then back for banks to give me like a few million bucks. And, you know, to start that from scratch. And he was like, no, no, go talk to 3i. And it was actually interesting because it felt like. More being a suggestion even coming from the investor side and saying, well, you should actually start a company. And so it became more a conversation rather than a pivotal moment in time. And it was basically after I left my prior job and in that connection. And it was still during COVID. So it was basically, you know, beginning of 2021, where I think a lot of us actually asked themselves about what's important in life. What's your purpose in life? What's your ikigai? Why do you drive to an office every day instead of, you know, working remotely and spending time in family? And all of that stuff was a very timely coincidence. I think thinking about, what is important for me in the company, in the workplace. And I thought I was really intrigued about the idea we can start a company on the back of everything that I learned as a company where I thought, this is really good stuff and this is maybe stuff that I would like to do differently. And then basically built a company around that. And that's exactly how it formed. And it was also coincidental that I made a sustainability training with Cambridge and I made an organizational development coach training with an organization in Berlin. So basically putting the... The pieces together of, of, you know, knowing. What I'm good at technically and, and the company that I can, I can do in, you know, sterile. Product and combination product development and manufacturing combined with maybe the The motivation of driving an organization was just differently from how we organized and having a very strong sustainability footprint and idea and driving that forward. So that were kind of the three elements that came together in the beginning of 21.
Mathias - 00:18:25:
This is great. I mean, my next question actually was a little bit something along the lines because I understand from many folks in the industry as a CEO, I mean, you spent... A bigger part of your time really raising capital. But you have a really very interesting story you just shared with us. So this is great. Just another question. So obviously, your stuff is always on LinkedIn. And this is now a few months back, but you obviously had like a grand opening on September 23. I mean, always a bit late, but on the other hand, you acquired Sphylon, et cetera. So it makes sense. But tell us a little bit, how did that milestone actually feel? And what did it also symbolize to you and your team? It must have been a really great day for everybody.
Announcer - 00:19:09:
Yeah, no, absolutely. And I mean, as of today, Ten23 is roundabout, you know, three and a half years old. We launched the company in September 21. And as you said, we acquired the company Swiss Fillon at the time, which is meanwhile also renamed to Ten23. And the acquisition was also six weeks after we launched the company. So that was a very interesting timeline, I would probably say. And even at that point of time, it was clear that, you know, there's one fill line, one fill facility that we have with a focus on ready-to-use containers. So syringes and cartridges and vials and ready-to-use formats. And it was very clear that from a scale and capability perspective, we want to grow and we need to grow. And from what, you know, customers, but also the market basically needs. And that was a project we kicked off very early already in 2021 to, you know, have a separate facility. With additional capacity, additional capabilities. And that on this grand opening, this facility, which we call Viva 2, Visp Valley 2, we basically have this, you know, larger scale version of the ready-to-use fill, multi-dose filling line, multi-purpose filling line, very flexible filling for syringes, cartridges, vials, which is basically an 8x scale up of our existing line. Plus pivoting into an additional technology for Ten23, which is basically more standard bulk vials, also as a clinical service form. Plus lipholizing, lipholization with 12.5 square meters. And then we also added a QC lab basically into the new building, which has been successfully inspected now in November as of last year. So that grand opening was really... A huge moment of pride, of feeling, oh my gosh, it's been a journey that we kind of kicked off on day one. It's basically a greenfield or brownfield of adding two more sterile fill lines as an organic growth of a company, which is not very old, adding QC Labs. So I would probably say it was a... A great moment of pride. And it was a wonderful moment also for all the colleagues that basically attended the meeting. It was definitely one of the most memorable things to think of in 2024.
Mathias - 00:21:46:
No, no, it's interesting. It was actually great. I wanted to also ask you a bit more about your core business, but I think you already kind of anticipated that question, which was interesting for people who like geography, is that my understanding is that Swiss Fillon, so a bigger part of the operation, is actually one of the probably most beautiful parts in Europe, if not the world, like really in the middle of the Alps. Didn't quite make it yet. I like Basel too, but my understanding is it must be really, really amazing. When we look at your business, what also interests me, who is actually your core customer? Maybe a typical customer. I mean, I'm sure you've got also some that maybe you're expanding services. And how do you actually tailor your services to meet their unique needs? Because I'm pretty sure every customer is different.
Announcer - 00:22:40:
Great questions. Maybe just coming back a little bit to the core offerings at Ten23 Health. We offer development, manufacturing and testing services for sterile products. And I think as an example on the development side, so we do offer formulation development. We can service customers as early as supporting them and making a selection, which, for example, which antibody, which by specific choose from a, you know, developability formulation standpoint, et cetera. Also like in a phase zero candidate selection environment and taking the stuff into development, we can develop analytical methods, you know, and then take them to preclinical material, clinical material and commercial material on the manufacturing side, plus then adding the related testing and QC services. So I would probably say we service a broad space, especially with manufacturing development and testing. And I think we're kind of uniquely positioned because many. Many places you see formulation CEOs, you see different fill and finish organizations, and then you see different QC testing organizations. I truly believe that magic actually happens at these interfaces. So it's very important to know the primary packaging that the formulation will go into. It needs to be considered in the development. You need to know how to produce it, how basically the testing actually and the control strategy is set up, because it totally links to the development and manufacturing. So that's why I believe these three pillars help us a lot. And as you rightfully said, we have spread these three activities around our two locations in Visp, Valais and in Basel, both in Switzerland. And I think both places are beautiful. Basel with, you know, swimming in the Rhine in the summer place. And in Visp, it's like in our typically a great... You know, a place that many people would know would be Zermatt. So we're just an hour from the site and it's everyone going to Zermatt would actually pass on a new location as well, just on both by train and the highway. And so that's a little bit our core business, our uniqueness. And this is where customers, I think, also look at us, is exactly that combination of development, manufacturing, and testing services. So someone who needs a more comprehensive and holistic approach to the services. At the same time, we also have customers just leveraging us for development services, for individual studies, for development, in-use compatibility, dilution schemes. For formulation studies or just for the manufacturing pieces or just for the testing. And that's where I think we're also pretty flexible on how to address customers' needs. On the formulation side, we do have quite a bit of expertise and programs who are going to sub-QI intravitreal. So speak about the typical high concentration, high viscosity kind of programs. Which is kind of a unique approach. And then on the filling side, also, as I mentioned, the filling of syringes and cartridges, we're also pretty unique because we have quite some elaborate process controls and process designs about what we do. We can handle novel containers. We can fill polymer containers. We can fill 0.1 milliliter with a 2% precision, which is kind of unheard of, no air bubbles. And I think all these features actually allow quite well integration with devices where, you know, imagine when you don't have an air bubble, you don't need priming or you don't lose, you know, have a lot of risk when you down dose these for intravitreal and, you know, things like that, or you don't have risks for CCI and air transport and all of that. And that's where I think customers actually seek us out for that speciality knowledge and speciality capabilities. And our customers hence also range from startups that are in an academic state and haven't even defined their name and spinning off. To customers and seed funding series A, more medium-sized pharma we work for, but also for top 10 pharma. So we have a range of top 10 pharmas that we're currently supporting, which is also filling me with great pride because it basically also means that top pharma companies consider a company at the size of Ten23 still being a competent partner. And we are just, I think we are currently 210 people in the organization. So I would say we are still fairly small organizations, although I would say for a three-year-old, quite organically grown company, I think it's still quite sizable.
Mathias - 00:27:40:
That's actually quite impressive. I mean, when you mentioned your uniqueness, I was actually thinking along the lines, okay, what are kind of core customers? But it seems to me that with what you guys are doing, I mean, you can really, as you said, I mean, serve the whole range of like pharmaceutical companies. And of course, I mean, you also like work, obviously with device, primary container, partners, et cetera. So if we want to look ahead and also kind of getting to a closure here, so where would you see Ten23 Health moving in the next, let's say, three to five years? And what will also key partners play in shaping that kind of successful journey?
Announcer - 00:28:22:
So, maybe also to the partnerships, and you said it rightfully, I think there's a range of, I truly believe that in partnerships and collaborations, and I also think that the traditional way of thinking about competition is probably a little bit obsolete. So I think it's a little bit more thinking about synergies and what people can work collaboratively for the benefit of joint customers, but eventually patients in the end. And we have had a couple of announcements on collaborations. We've been collaborating for a range of years, filling the West SmartDose 10 mL. We've been just announcing a collaboration with BD on the RFID-TACT pre-filtration range implementation. We've been working with SHL. We are currently supporting the filling and assembly of the Ipsodose OBIs, just speaking of OBIs, because you also mentioned that. And there's a range of partnerships which are obviously, very important. And I'm also looking forward and hoping for more closer collaboration with Kymanox, obviously. And I think that's where... I think the future will hopefully see more partnerships across the industry and people being less scared of working together. I'm hoping for... Hence, breaking down silos and connecting the pieces of the puzzle that I mentioned initially is to make sure that there's no separations on this thinking with primary packaging and device and formulation and filling on the other side. I think we can help bridge that. I'm not a big fan of jumping on specific trends necessarily. So I hope we can help to innovate and break down, let's say, urban myths when I just mentioned this injection volumes discussions. I think there's plenty of urban myths and startup product development. I think people need to get more creative. I think we can help to actually provide agility and flexibility on that end. And that's why I think we will be kept busy in the years to come.
Mathias - 00:30:34:
Clearly. This is great. Notice that you definitely have a good vision here. And again, kudos to you and your team. It's actually always quite amazing to see a totally new business emerge and really providing value to so many. People in the industry. And again, it's going to be fun again, I think, being in 2025, I mean, meeting with you, your team, other peers at all those conferences and then continue that conversation. Unfortunately, I think we're out of time. So I really hope... People enjoyed listening to the podcast. Hanns-Christian, a special thank you for you sharing those insights with us. It was really great. And also wishing you a lot of success moving forward. Thank you very much.
Hanns - 00:31:23:
Thank you and looking forward to see you at the next conference Mathias. Thank you.
Announcer - 00:31:31:
Thank you for tuning in to Life Science Solutions presented by Kymanox. A big thank you to today's guest, Hanns-Christian Mahler, for sharing his insights on innovation, challenges, and the evolution of our industry. For more information on Ten23 Health, visit ten23.health. That's T-E-N-2-3 dot health. And for more information on Kymanox, visit kymanox.com. This episode was edited and produced by Earfluence. Until next time, this is Life Science Solutions, where challenges meet innovation.