Moving into GMP – Turning process into product
The complex journey of bringing a biologic to market – part 4 The transition into GMP manufacturing marks a defining moment in the development of a biologic drug. After extensive ...
Ola’s Insights and Future Perspectives from ISEV 2025
Looking back to April this year, the world’s most renowned experts in the field of extracellular vesicles gathered in Vienna for the ISEV Annual Meeting 2025. The biggest vesicle gathering in the world and I was fortunate to have had the opportunity to join. For me, coming from the biotech industry, it was a chance to step into an exciting environment of academic and applied research to listen, learn, and reflect on where this young field might be heading.
Walking through the poster halls and lecture rooms, I couldn’t help but think back to how other therapeutic modalities once started. Monoclonal antibodies in the late ’80s and mRNA just over a decade ago. At the time, there was significant interest as well as some skepticism regarding the potential for these treatments to become legitimate medicines. Over time, they have evolved into widely utilized therapeutic options.
EVs today feel the same. It’s still early, still about figuring out the basics – but the promise is huge.
The idea of using vesicles as vaccines or delivery vehicles is elegant. Nature already designed them to carry messages between cells. If we can harness that, they can carry drugs, RNAs, or proteins into places we’ve struggled to reach – perhaps even across the blood-brain barrier.
One thing that struck me at ISEV was just how much talent is in this community. The level of science was impressive – from biology of vesicle formation to applications in new tools for analyzing and isolation. For someone used to living closer to GMP facilities and manufacturing questions, it was refreshing to dive deep into some of the basic research laying the foundation for future applications.
In addition to the academic groups, a large number of companies attended, demonstrating their services or products – start-ups and young biotechs looking to bridge the gap between discovery and clinic. You could feel the entrepreneurial energy buzzing alongside the science.
Many highly interesting lectures and speeches were given, ranging from detailed research results to overarching talks pointing out challenges and successes in the field. Among all the talks, the plenary speech by Jan Lötvall stood out. He reminded the audience of how the field evolved from the early days and how persistence and evidence slowly enabled the journey from foundation research to viable applications. It felt a bit like listening to the “origin story” of the field, told by someone who helped shape it.
For me, his talk captured the essence of where EVs are today: the excitement is real, the challenges are significant, but the long-term potential is worth the hard work.
Of course, from an industry perspective, I kept thinking about the hurdles:
These are tough problems, but not unfamiliar. We’ve seen other modalities work through them, step by step.
What excites me is the breadth of applications. EVs could touch everything from oncology to neurology to vaccines. And if history is any guide, what feels speculative today might be standard of care in 10–20 years.
For NorthX Biologics, and for CDMOs in general, the big question is: how can we support innovators in this space? How do we help them move from exciting lab data to clinical-grade material that regulators will accept and patients can benefit from?
Leaving Vienna, I felt both humbled and energized. This field is young, yes, but the energy, the intelligence, and the creativity I saw at ISEV 2025 made me think: this could very well be the start of the next therapeutic revolution.
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide and in 2021 was recognized as a national innovation hub for advanced therapeutics and vaccines. NorthX Biologics has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.
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The complex journey of bringing a biologic to market – part 4 The transition into GMP manufacturing marks a defining moment in the development of a biologic drug. After extensive ...
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