“São as águas de março fechando o verão”

It’s the waters of March closing the summer

– Antonio Carlos Jobim

The Waters of March that mark summer’s end in Jobim’s Brazil also herald renewal. In this discussion blog, a team from RoosterBio reflects on the ISEV2025 and ISCT2025 springtime conferences from the rear-view vantage of the September equinox. The conversation blends fresh ideas flowing into established currents— endings that cycle into beginnings for MSCs, CAR-T, extracellular vesicles (EVs; “exosomes”), and other cell therapy modalities. In that spirit, this dialogue revisits what RoosterBio’s team carried forward from its colleagues on three continents, [1] and how those insights continue shaping the path ahead for cell and gene therapies.

 

Jon Carson (Carson):
So I’d like to welcome all of today’s participants in the Spring Conferences interview recording and thank you for your gracious time and effort here. This will be turned into a blog to help the world to know us a little better—and about how we dynamically interface with our customers’ needs. But if you please, let’s begin with name, title and when you joined RoosterBio, and then we can proceed with questions. How does that sound?

Jon Rowley:
Sure. I’m Jon Rowley. I’m the Chief Product Officer at Rooster Bio, and I founded RoosterBio almost 12 years ago

Terri Willstaedt:
Hi, I’m Terri Willstaedt. I’m the Senior Manager of Product Development on the MSC side, and I’ve been here for almost seven years.

Mary Doolin:
Hi, I’m Mary Doolin. I’m the manager of our IPSC product development team, and I’ve been with RoosterBio for four years.

Stephen Lenzini:
Hi, I’m Stephen Lenzini. I’m a Senior Scientist here at RoosterBio, working mainly now in analytical development. I’ve been at RoosterBio for four years.

Elie Zakhem:
Hi, I’m Elie Zakhem, Associate Director of Analytical Development and Services, and I’ve been at RoosterBio for about four years.

Julie Diamond:
Hi, I’m Julie Diamond. I’m a bioprocessing sales specialist at Rooster, and I have been here for about 2 1/2 years.

Carson:
Cool. All right. So, let’s start with the first question. We avidly participate in spring conferences year after year. And I know that you’ve all been to ISEV and ISCT. And in 2025 we were at ISEV and ISCT, [1, 2, 3, 4, 5] enthusiastically participating. Is there any gestalt that can be captured from that leading edge of cell and gene therapies in 2025? …For those of us who might have missed these events.

Jon Rowley:
Yeah, I can start here. I think across these different conferences, the main kind of take home that I had was that the advanced therapies are both maturing as industries as well as branching into new territories.

We saw some of these traditional cell therapies like CAR-Ts and MSCs focused on manufacturing robustness and getting more patients treated with a consistent product—and of course, the first FDA-approved MSC therapies like Mesoblast’s were highlighted. [6, 7] Both of these types of therapies are also moving into newer indications – showing a maturation of the tech. For example, T cells outside of oncology. [8, 9] We saw a couple of really interesting keynotes at ISCT on CAR-T expanding into immunology indications, and then MSCs showed up in a Type 1 diabetes keynote by Camilo Ricordi on helping in type one diabetes with islet transplants, [10, 11] and he even showed compelling data on MSCs in longevity. [12] The longevity in particular, I’m excited about, because it’s becoming more mainstream and I saw multiple laboratories sharing scientific data… Whether it’s extracellular vesicles or MSCs with longevity and anti-aging as the indication, regulatory conversations have begun moving toward this topic. This has been more in the realm of science fiction in the past.

At the same time, extracellular vesicles (or exosomes) are becoming much more prevalent. There were several dedicated sessions and panels at ISCT this year, and there’s definitely growing recognition that potency characterization—specifically along the lines of things like CD73 activity [13, 14, 15] —will be central to progression towards clinical trials. And then, there’s definitely this clear shift towards solution-focused science as opposed to just asking scientific questions. Because there it really is about how do we get these interesting molecules that do lots of different things through the complicated pre-clinical review process. And then, just like you see every year, I think the scale and sophistication of the exhibit hall truly underscores the continued growth within cell gene therapy… Lots of manufacturing innovations… IPSC technology is becoming more common, and you see a lot more of the CMC pipeline and these types of themes all around the exhibit hall and as well as in the is in the sessions. And that the vendor ecosystem is just becoming increasingly diverse. So, I think these were great meetings and so much more progress is being made in this every year. We haven’t made it to the big time yet, but we’re definitely getting closer.

Carson:
Thank you, Jon (Rowley). OK, let’s move on to another question about our posters at both conferences (ISCT and ISEV). I know that we presented six or so, including an award-winning abstract by our own Maddie Cramer, PhD. [16] Would someone like to highlight briefly the discuss what was involved with the work?

Stephen Lenzini:
Sure, I can start. I can talk about what our analytical team focused on with our presentation. We had some posters, and as you mentioned, and Maddie Cramer gave an excellent podium presentation at ISCT that was focused on using nanoflow cytometry as a method to do single particle analysis. [16] The capability to measure individual particles—and how many molecules—of a certain antigen are on their surfaces is something that the field has been really interested in for the last decade. Maddie fully developed this new protocol and presented it at ISCT. We received a lot of great feedback and discussions on that and a couple other related posters. CD73 is a huge new player gaining traction over the past few years for extracellular vesicle function and potency, and so we also presented a poster on our CD73 potency assay development. Additionally, I presented a poster on analysis of EV (extracellular vesicle) samples generated from different upstream conditions, such as the kind of bioreactor platform, MSC tissue source, and donor. [17] We found that—for the most part—the EVs are pretty similar, but there are differences that we can measure using our wide suite of analytical methods. This emphasizes the importance of screening different donors for your EV application.

Carson:
Any other thoughts on the posters?

Elie Zakhem:
You can tell our type of work involves identifying some of the problems in the field and implementing integrated product and process solutions. Many traditional assays now only measure bulk characterization of the extracellular vesicles. Single vesicle analysis is something that helps researchers understand more about the heterogeneity of their EV populations. The other thing that’s heavily discussed is potency markers or potency assays like CD73 activity. Thus, we offer researchers who need a quick potency assay to demonstrate that their EV samples contain the activity that they want. We also presented another poster around our recently launched product, AgentV-DSP™. [18, 19] The main challenge when you’re purifying EVs is you lose a lot through filtration, and with every step that you add, you’re losing more EVs. With AgentV, we enable much higher recovery of EVs and with that, a reduced cost of goods. There was another poster that Terry or Mary can speak more about on RoosterHD™-EV ( i.e., our chemically defined EV collection media/platform)…

Terri Willstaedt:
Yes, I can chime in on that one. We had a poster on the development of HD-EV, a new chemically defined medium for growing MSCS and for collecting the EVs that they produce. [20] We described the characteristics of the medium and of the vesicles that are harvested from that medium. The EVs are highly produced in this chemically defined medium, and they can be collected over a course of 12 days. Importantly, no media exchange is required using HD-EV medium, so one can collect rather than discard the EVs produced during the cell growth phase of the culture.

Elie Zakhem:
I think a lot of the people are very interested in how you characterize your EVs, and they’re noting how effectively these assays can detect differences. Because MSC-EV heterogeneity was a major topic at ISEV, attendees were motivated to understand how much those assays are detecting real differences between different EV/exosome samples, and this is where single vesicle analysis provides an advantage to further understand heterogeneity of EVs. There was also a big interest in identifying or developing quick potency assays, and this is where the CD73 activity assay comes into play. We have it developed and qualified at RoosterBio and can be easily implemented with customers. [21] In our study, where we investigated EVs from different tissue sources or donors, we addressed many of the researchers’ interests.

Stephen Lenzini:
At ISCT, I noticed a lot of recognition and feedback coming from our growing expertise in EV analytics. A lot of the feedback relates to questions on the relevance of CD73—and I think that’s going to be really indication dependent. At the same time, we received a ton of interest in single vesicle analysis methods after Maddie’s presentation.

Carson:
So here’s a question about ISEV-2025. We all know that exosomes and/or EVs can be used as sample materials for medical diagnostics, but also they’re now emerging as therapeutics, too. What were the ISEV participants seeing as the promise and challenges of EVs as a prospective drug platform?

Elie Zakhem:
Yes. It’s amazing how much this field has been evolving at ISEV over the last few years. At prior ISEV conferences, most of the questions were basic scientific questions. What I noticed this year was “What do I need to get to a Phase I clinical trial?” [22, 23, 24] – a shift from basic science to translation and how to proceed through regulatory. There were many discussions around having all documentation in place, including manufacturing processes and analytical characterization methods. There was a big emphasis on characterizing the EV product within a CMC context. How you can identify right-fit assays for identity, purity, safety, and potency with credible mechanism of action for the EVs/exosomes.

Carson:
To add to that, the number of EV exosome trials is growing geometrically year to year. It looks like a very encouraging decade ahead, despite the challenges. This segues right into the next question: any consensus shifts that you all might have noticed in your conference travels?

Stephen Lenzini:
At ISCT, there’s a huge focus every year on MSCs, but even more so this year with the recent approval of Mesoblast’s Ryoncil. Consensus is firmer for MSCs than their EVs, as one would expect. For example, there was a recent nomenclature paper published in Cytotherapy that was introduced at the conference, which solidified the term “stromal” as the “S” in MSCs versus “stem.” There’s much less emphasis on “stemness” for MSCs, which has important consequences for release test panels, like trilineage differentiation assays, becoming less emphasized. [25] I noted that the scientific line between MSCs and fibroblast is becoming blurrier every year, but that could be a topic of its own entirely discrete section.

For EVs, it seems like there’s still two main camps, where one camp has had a lot of success in evaluating EVs for their RNA content (including microRNAs), [26, 27] and claim that specific indication-dependent RNA species in EVs are highly potent. The other camp doesn’t believe that there’s any biologically relevant amount of microRNA in EVs. So, that debate is still really lacking in a definite consensus. However, there’s a lot stronger data this year on CD73. People are starting to block or knock CD73 down, and link these results with their potency assays, confirming the relevance of CD73 to EV function in vitro and in vivo. So, with CD73 activity, they’re able to measure EV potency, but with it blocked, the potency effect goes away, and then they’ll see this dose response of activity in their preclinical data. That’s coming from a couple of indications, including one osteoarthritis model. I would say Professor Sai Kiang Lim has always been leading the effort to zero in on the mechanisms driving potency. [24, 28] She presented a very strong rationale to the community to focus more on external players that express on the surfaces of EVs that may affect the EV signaling environment [29] —versus a fixation on the internal contents of EVs like RNA species. I would say that amounts to a big shift in paradigm. There’s a new appeal to explore the “outside-in” signal transduction that affects not just one cell target, but potentially many cells at once.

Carson:
OK, let’s shift gears a little bit. I’m really curious about not just at the posters or watching the talks, but some of the conversations you might have heard in passing or… just the more informal conversations, the “vibe.” From that atmosphere, has anything made any of you rethink or that you might have previously assumed about the future of MSCs or cell therapies?

Julie Diamond:
I can hop in. I don’t think there was anything that fundamentally changed my outlook. It’s interesting to see how the field is evolving, like Stephen mentioned, and with the approval of Mesoblast’s MSC therapy (Ryoncil), the MSC community is very excited. It looks like a lot of folks are moving towards MSC and EV therapies that layer in some sort of differentiating intellectual property with cell engineering, [30, 31] or unique manufacturing processes—things that are going to improve or specify stronger potency depending on therapeutic areas that different companies are working with.

And then also I think there is a lot of attention in the EV space on consumer markets as well. You know, there were certainly some murmurings about that in the halls and at the booth, to use EVs for cosmetic applications! I think there’s a lot of innovation and lots of new markets that MSCS and EVs can enter, and there is also a really interestingly evolving regulatory landscape that appears to be changing state-by-state. We and others at ISCT noted Florida’s recent passage of SB1768 legislation for stem cell and regenerative medicine use. So there’s a lot going on. I think much has changed in in the past year or so for MSCs and EVs/exosomes. It’ll be really interesting to see how the therapeutic and consumer, and more experimental uses are going to evolve.

Jon Rowley:
Yeah, I would echo that. I mean, I think that this “right to try” legislation is really interesting. I always have hallway conversations on these kinds of side uses of MSCs. This year, I’ve had more conversations with some of the clinician researchers who run their GMP manufacturing sites at academic institutions, and they’re all pretty well versed in how MSCs are being used in these applications… While they insist they’re not doing it themselves, I do think that many are being solicited as consultants for many of the longevity clinics that are located around the world. And then with the whole “right to try,” I think that, especially if data is collected and then used towards regulatory approval of some of these, this presents a compelling opportunity for MSCs and other common cell therapies and EV/exosome therapies to be tested. There’s a lot of interesting stuff that is going on kind of beneath the surface that people aren’t really going to be presenting at these conferences. But as time goes on, it’ll become—for better or for worse—common knowledge on what is working and what is not.

Carson:
So… did any academic groups or early-stage companies stand out to you as bringing fresh thinking or disruptive tools to what we do—or some of our peers might be doing—like with respect to bio manufacturing analytics or delivery challenges? What advice might we have for some of the others in the space that we’re rubbing elbows with?

Terri Willstaedt:
The first example that comes to mind is from a poster from the Belgian company called Trince that offers transfection methods that are alternates to viral vectors and electroporation with their technique of photoporation. [32] They use an instrument called the Lumipore. It’s a device that’s pending a patent and what it does is it uses laser exposure and photothermal nanoparticles for intracellular gene delivery. It can be used on suspension and adherent cells. It is said to be very gentle on the cells and can successfully transfect even difficult-to-transfect cells. For example, iPSCs are said to maintain their pluripotency and their differentiation potential post photoporation, and T cells are said to proliferate almost immediately after the process. The cell viability and delivery percentages are very high, greater than 90%! Interestingly, this technique can be used in a GMP-compliant clinical setting. This is intriguing to me because we here at RoosterBio grow all kinds of sensitive cells that are affected negatively by electroporation or other transfection methods. Photoporation might be an interesting avenue to explore for those who have these sensitive cell types that they want to get genes into.

Another example comes from the company, BlueWhale Bio, with their product Synecta. This product is comprised of cell-derived nanoparticles that are used to activate T cells. This is the first GMP product of its type to be used in clinical trials. For cell therapy use, T cells need to be activated first. Using Synecta, one can achieve Day Zero activation without cytokines, without the need for any of the complicated processes like de-beading or residual testing, because these particles are fully biodegradable. BlueWhale commented that activation with magnetic beads is not as efficient as this new technique is, and moreover, activation with the antibodies will also often result in over-stimulating T cells. This does sound like a new and easier-to-use activation method for T cells.

Carson:
Wow, that sounds really amazing! Thank you, Terry. Any others?

Elie Zakhem:
From the analytical perspective, I observed that with a lot of the early-stage companies, there are so many techniques that are coming out for particle count and size. Researchers are still unsure which platform is the best one to use in terms of accuracy, sensitivity, and reproducibility. This is where the importance of orthogonal techniques comes into play. Another driver for so many companies involves technologies for quick isolation of EVs for analytical purposes to avoid working with crude conditioned media. While many kits are available, one important thing to keep in mind is the reproducibility and consistency of the technique. [33]

Carson:
For those of us who weren’t able to attend, can you describe one session, or speaker, or workshop, that really resonated with you, where you’d just would want everybody to go back and recap for available recordings to reflect on?

Mary Doolin:
Yeah, I don’t think I can pick one! It was a great conference with lots of great sessions, speakers, and workshops. Yet the ones that shined most for me personally the most were presentations in what they called the Innovation Zone of ISCT-2025. Several start-up companies presented their products or processes. From that, I obtained a really good sense of where the field is going and what people are thinking about. That was interesting, especially from an IPSC standpoint. There was one company, faCellitate. They manufacture a coating for your tissue culture plastic. And in contrast to what you usually do, which is, take an ECM protein, put it on your flask, and wait, usually like an hour for that to coat… They claim you can wait as little as I think it was 10 to 15 minutes, maybe even less. Which really helps streamline IPSC processes. So that was really cool. Osprey Bio also had a talk discussing how they are using multigenic tools to accelerate the space towards next-gen therapies. In addition, there was one roundtable, in particular, regarding how do we scale IPSC therapies? That was another great talk that I would highly recommend. I was actually fascinated that folks, even in the academic realm that don’t normally seem focused on manufacturability of therapies, were becoming much more engaged in how can they scale their cell process. So that was really encouraging to see. I’d definitely recommend checking out that roundtable to anyone who couldn’t attend that corner of ISCT-2025.

Carson:
Yes! Thank you, Mary!

Jon Rowley:
I’d add that one of the sessions that I went to is on the regulatory frameworks that are emerging in Asia. One interesting model that was presented was from Taiwan. They’re progressing with what I think they call the 2024 Regenerative Medicine Act, [34] where, from my understanding, Taiwan’s taking this unique approach, allowing certified hospitals to provide advanced therapies using a risk-based framework. What they seem to do is approve a hospital first and then allow it to provide certain treatments like autologous cells, even cell-based gene therapies—with just enough government oversight—but not so much regulation that takes forever to get things tested initially, right? And then, when things look promising, the hospital allows patient access while, in turn, more crucial additional and safety and efficacy data can be generated. This conditional, time-limited approval—based on real-world evidence—provides a bridge to streamlined commercial approval from a formal regulatory pathway. It looks like this revised system is designed to protect patients from the risky stem cell clinics, while providing a path for patient access to the novel cell gene therapies faster than the traditional regulatory pathway would allow as well. I believe the goal of Taiwan is to position itself as a kind of regional hub for advanced therapies. It definitely looks like there’s a lot of novel regulatory experiments that are being tested in Asia, and you know, that looks really exciting.

Carson:
There’s this eternal question about scalability, a subject that I believe is near and subject near and dear to RoosterBio’s heart. But how do how do our peers think about the evolution of scalability between R&D and GMP at the conferences that we saw? And are they talking about it differently now than, say, a couple of years ago?

Jon Rowley:
I can chime in on what I saw this year… So you know, scalability is this recurring theme over the years? I’d say that the way that it was talked about this year has evolved. Historically— and we talk a lot about this right here in cell therapy manufacturing circles—it’s all about scalability and getting to commercially relevant lot sizes. [35] And it’s been traditionally from small scale 2D flasks and getting into 3D bioreactors. And this is a very allogeneic approach, where MSCs have had a very hard time getting approved the last dozen years. This conversation’s certainly still important, but what’s changed is that over the last few years there’ve also been several autologous therapies that have been approved. I saw—time and time again—that scalability discussions were focused on scaling of autologous patient-specific therapies, these autologous CAR T therapies that are already approved and commercially available. But patient access is a challenge. So this conversation is now about whether scaling patient-specific manufacturing is done efficiently. It is all about robotic process simplification, shortening production timelines.

And it’s all around how many individual products can be produced, in parallel, at the same time using automated lines—big, automated boxes with very expensive one-time use consumables. But then, you’re not saving time on the labor and time in a clean room. And so, they’re very different scaling challenges, but these are just as relevant to the new commercial products, and I believe a lot of investment is going into these. But only time will tell on if automation robotics is going to really help to bring the cost down of these very expensive autologous CAR T therapies. I do think allogeneic MSCs and then especially MSC-EVs—as they gain more and more regulatory and commercial traction—will fit with automation. With the recent approval of Mesoblast’s product becoming more cemented within the market, we’ll see the discussion get back into the scalable bioreactors. But yeah, I definitely just saw different themes this year.

Carson:
That’s fascinating, Jon. Thank you. Any additional thoughts we’d like to add to that about scale-up and how the 2025 conferences brought new facets to light?

Mary Doolin:
Yeah, I can just make a quick note too. Most of my experience is with MSC scalability. So now I’m wondering about IPSCs and particularly the reprogramming process, as in how we make that scalable and efficient. I was really interested to see how folks are using advanced algorithms and robotics for, say, colony picking of IPSCs, and how can we use AI to our advantage for these processes. That was interesting and definitely new to me, pretty cool to see.

Carson:
Interesting. Bringing advanced automation tech into the equation of cell therapy scalability! But think this is most of the questions. I think that just about wraps it up. Thank you all for your time and brainpower!

 

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