Podcast Transcript

David Brühlmann [00:00:34]:
Welcome back to our conversation with Sandra Núñez, who’s the CEO of Amela Biosciences. Here’s something worth sitting with. Her company owns no factory, no cleanroom, no fermenters. Everything runs through external partners. It’s a virtual plant model built entirely on outsourcing.

We picked the conversation back up there, moving into CDMO selection, technology transfer surprises, quality control outside your own walls, and the regulatory shifts reshaping animal-free manufacturing. Let’s get back into it.

Let’s look at your strategy. You chose to transfer the protein production from the academic lab directly to an external manufacturing partner. What does that tech transfer involve in practice, and what were perhaps some surprises you came across?

Sandra Núñez [00:02:48]:
I would consider it at that time to be more a drug substance tech transfer. So there are, like, the strains involved that we need to transfer. There are strain development activities perhaps that we need to do. And then it’s really a fermentation upstream process or other platform that has to be introduced in the facility with, I would say, a very short purification train. And then the filling, that may happen at the same facility or something we need to outsource.

So we are currently in the process. And that’s what is typical for a tech transfer. You need to have the agreements in place, you need to have a tech transfer plan, you have to have selected the partners you want to work with, because our strategy involves high-throughput screening, for instance. So we need to select partners that have these capabilities for strain screening, for small-amount production of proteins, so that we can commit to our customers to providing them with a minimum viable product within a certain time.

So our team comes from CDMO activities, from CDMO companies. So we are quite proficient in that area. And therefore, we also know who to partner with. And that is important.

I think one of the major pitfalls that I have experienced in tech transfer is not, I would say, even the technical part, it’s really the human part. So the collaboration aspects, politics between two companies, interaction with the teams. And this is, for me, one of the aspects that is usually underestimated and where some of those tech transfer projects may struggle.

David Brühlmann [00:04:34]:
Yeah, given the complexity of a CDMO model because of culture, because of other misunderstandings, sometimes people compare it actually to marriage because you have to enter into quite a committed relationship over a long period of time. Why did you choose this fully outsourced virtual plant model with no in-house manufacturing?

Sandra Núñez [00:04:57]:
I think it’s a timing question, really, and then also having had good experiences with that model in the past. For me myself, as a former tech transfer manager, I’ve been working in different constellations, either on the customer side with a portfolio of different CDMOs or on the other side within a CDMO. And it’s just, for me personally, it’s really a very agile model.

We can get fast to a result. We don’t need to build those capabilities ourselves. For a startup with little money at the beginning, it is a good start, even for a certain horizon, time horizon, to just have also products in hand within a short time and being able to actually do that beta testing with the customers.

So for me, it’s really the agility outweighs, let’s say, maybe the drawbacks you may have on the marriage. And in our case, I would say we are not yet in a very complicated situation, also from a regulatory point of view. So right now we are at the stage where it’s pretty straightforward.

And we have the opportunity then also to grow from a regulatory point of view with the CDMO. And of course, we are looking for those partners that have these capabilities so we can scale, not only volumetrically, but then also regulatory-wise as we move along our lifecycle, our company lifecycle.

David Brühlmann [00:06:28]:
What are the key selection criteria you would advise a startup founder listening who also thinks, well, this could be an agile model? What are the most important things to watch out for?

Sandra Núñez [00:06:40]:
I think the capabilities should match what you would want to do strategically as a company. You should, I think, consider them as a sparring partner. So knowing that you can openly discuss things, that you are involved in their processes.

Again, I would say it’s a customer preference as well, but I would, for instance, select for a CDMO that has rather a collaborative culture that is also open to adapt or even to find solutions. I think you can achieve that by really going onsite.

I think one important piece is really to be onsite, to do due diligence, to walk the process, to discuss with the SMEs. So these would be my pieces of advice: technical capability, but also cultural fit.

David Brühlmann [00:07:33]:
And what is this model demanding of you? You are still a young biotech, perhaps people who come from different parts of the industry. How does that work?

Sandra Núñez [00:07:44]:
I think for stakeholders of our company, it is important to explain that it is not as complicated as it may sound to, for laymen, laywomen who have not worked in that setup. It’s my work or our team’s work really to explain what it encompasses.

It’s beyond just agreements, also to watch out for capability constraints in the future. These kind of things and also kind of outline the risks or the advantages that you may have with the model. I think for us as a team who have been in that business for so long, it’s—we are not scared about engaging in such a relationship. And I think it’s really more for stakeholders that do not know that model.

David Brühlmann [00:08:35]:
Now, you have already put your product into the hands of customers. You’re talking to them. You’re further improving, adapting, and I imagine as the demand is increasing, you have already encountered certain process development challenges. What were some of the challenges you have encountered?

Sandra Núñez [00:08:53]:
I think if you transfer a process from academia, which is—it is, it’s a good process. I like it because it’s lean, but then also, as a former fermentation expert, I obviously see areas that require improvement.

And those optimizations, we just need to be aware that they can have an impact on, for instance, the impurity profile. Let’s say if we introduce a fed-batch and before it was a batch fermentation, for instance. Or even also to be aware that if we go through those protein libraries, that there might just be variants that don’t express, that are just not producible at all.

And then also that certain process modifications may lead to a different behavior of the matrix. We are not expecting that because the protein is rather simple, as I said before, but these are kind of the considerations you need to take into account.

And then also pretty much assess the process itself. There are just methods that are not really scalable, and it’s better to do that now. Like, certain purifications are just not scalable because of the bed size. At some point, if I look ahead and I know I will have to scale to 1 cubic meter, then there are just certain purifications that are just not feasible. And then you need to redevelop that, which again could lead to an impact on product quality, which we just need to take into account too. Yeah. So that’s the difficulties.

David Brühlmann [00:10:31]:
Yeah, exactly. And I like that you’re highlighting that because I’ve talked to a lot of startup founders and I’ve noticed that certain people have not enough understanding of CMC and they think CMC is an afterthought. And what you’re sharing is that very early on you’re thinking ahead, okay, what’s coming up? What are the next steps? How should we improve the process? What do we need to do now so that we don’t run into the wall a couple of years down the road?

I’d like to know also what are your thoughts about potentially entering GMP manufacturing, because that will change the game significantly. How will that change for you? And also, more importantly, what are the things you’re already preparing now in order to be ready when it’s needed?

Sandra Núñez [00:11:20]:
So in that scenario, we would become a critical raw material for our customers because, as I said before, the matrix guides the cell behavior. It guides how the cells differentiate. So we will need to fulfill or be compliant with USP, European Pharmacopoeia requirements for a critical raw material.

And I think just by thinking of that potential, which is still far in our horizon, let’s say, five years from now, is of course to partner up, then also to foresee internally ourselves who we will need to recruit along the road to also build our own quality system. We cannot just outsource everything to the CDMO. We will need to grow ourselves in that direction.

And what I’m doing right now, without overkilling it yet, but it’s like we are working by applying some GMP practices already. If I look at my documentation, it is kind of sectioned into different chapters, it’s something we can just naturally do now as a, let’s say, company culture to just implement very basic things that in the end will help us to naturally transition into that regulatory framework.

David Brühlmann [00:12:47]:
And speaking of regulatory, how do regulatory shifts like the FDA Modernization Act 2.0 change the conversation you’re having with manufacturing partners, investors, and other stakeholders?

Sandra Núñez [00:13:01]:
For investors and also for us on the market, it is, of course, a push that the FDA, but not only the FDA, EMA, UK has also just recently published a guideline on the transition to new approach methodologies. That’s how it is called. So for us, it’s a push.

And at the same time the FDA just issued a guideline as to what a cell model needs to fulfill in order to be able to be validated, to be accepted, to be fit for purpose as an alternative to the animal model. And here we will also need to fulfill those requirements.

So it’s kind of going hand in hand. It helps us. It’s good also that it gives us guidance where we need to develop our products, and it will help us on the market because reproducibility is one of the key aspects that is written in the guideline that our customers will need to fulfill. And really, with our bioinks here, we remove that one variable because they won’t need to worry anymore about batch-to-batch variability.

David Brühlmann [00:14:09]:
If we had the opportunity to have another podcast interview, let’s say in three years from now, where would your company be at that stage?

Sandra Núñez [00:14:19]:
At this stage, I hope we will be the go-to enabler partner for the 3D cell culture community. I hope by then that we will have also made a significant contribution to the transition from the animal-based model to in vitro models for our community.

And I hope that by then we may have one or two customers that would like to engage into a regenerative or transplant product and to use our platform for that. That would be great.

David Brühlmann [00:14:57]:
That’s exciting. To a startup founder or somebody who is on the fence founding their company, what would be one piece of advice you would give them?

Sandra Núñez [00:15:09]:
Take the leap. Yeah, I think just do it. For me, I’ve been in corporate for the last 15 years and it is really so rewarding. I’m learning every day.

Also for me personally, it’s like I’m repositioning myself. You are way more exposed. You need to sell your product to different stakeholders, convince why it is beneficial. It’s really a 180-degree change compared to what I have been doing, and it’s really enriching. I have a lot of fun. Yeah.

David Brühlmann [00:15:45]:
How hard was that leap leaving corporate, leaving the security, now being in this unpredictable startup world?

Sandra Núñez [00:15:54]:
I think if you’d ask my former colleagues, they would say that’s just Sandra. It was not so difficult, honestly, because I had just left corporate for a one-year sabbatical. And that was during that time where this opportunity arose and I just said, yeah, I’ll do it. Yeah.

David Brühlmann [00:16:16]:
This has been great, Sandra. What additional questions should I have asked?

Sandra Núñez [00:16:22]:
I would not know right now. I think you covered pretty much what one could know. I would not have a further suggestion right now.

David Brühlmann [00:16:31]:
We’ve covered a lot of ground today. What is the most important takeaway from our conversation?

Sandra Núñez [00:16:40]:
I think what I also said at the beginning, that batch-to-batch variability is nothing you should be accepting and rather look for options either as part of your raw materials or your process design, or if I go further related to organ models, to the lab automation that you can improve so that you achieve a reproducible, standardized result. I think I recommend not to accept batch-to-batch variability as a normal thing.

David Brühlmann [00:17:10]:
Fantastic. Thank you for being on the show today. Thank you for sharing your passion, your exciting project. Where can people get a hold of you and perhaps even test your bioinks?

Sandra Núñez [00:17:23]:
Everyone can contact me on LinkedIn or through our webpage. These are the two channels that you can get in touch with us.

David Brühlmann [00:17:32]:
Great. There you have it, Smart Biotech scientists. I will leave the links in the show notes. Please reach out to Sandra and her team. And Sandra, once again, thank you very much for being on the show today.

Sandra Núñez [00:17:44]:
Thank you, David. Thank you so much.

David Brühlmann [00:17:46]:
This wraps up our conversation with Sandra Núñez. The through line of our discussion is that reproducibility isn’t just a lab problem. It’s a company-building problem, one that shapes manufacturing strategy, partner selection, and even regulatory positioning.

Sandra Núñez laid out how Amela Biosciences is navigating all of that without owning a single piece of manufacturing equipment. If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite platform. It helps other scientists like you find the show. Thanks for tuning in, and I’ll see you next time.