Dr. Blerina Shkodra, Chief Scientific Officer at leon-nanodrugs GmbH
Dr. Blerina Shkodra, Chief Scientific Officer at leon-nanodrugs GmbH
Dr. Blerina Shkodra, Chief Scientific Officer at leon-nanodrugs GmbH
Biography
Dr. Blerina Shkodra is a pharmacist with a drug delivery development background and currently serves as Chief Scientific Officer at leon-nanodrugs GmbH. She leads the company’s scientific strategy and manages R&D activities, with responsibility for nanoparticle formulation and process development. At LEON, she has driven technology and process development to enable robust, scalable LNP manufacturing, generating decision-enabling data to support process optimization and manufacturing readiness for both internal equipment platform and client programs.
Her work bridges formulation science, process understanding, and CMC considerations, supporting translation of nanoparticle products. Previously, she worked at CureVac on the mRNA–LNP vaccine development against COVID-19, contributing to process characterization, GMP readiness, and technology transfer. Blerina holds a PhD in Drug Delivery from Friedrich Schiller University Jena and is a published author in peer-reviewed journals in nanoparticle drug delivery.
Interview
NanoSphere: Tell us a bit about yourself—your background, journey, and what led you to where you are today.
Blerina: I come from a family of pharmacists who run a family business in pharmaceutical manufacturing, so discussions around manufacturing and medicines were part of my upbringing from an early age. During my pharmacy studies, I realized that my curiosity was consistently drawn to what were often considered “side topics” of the curriculum at the time, such as novel formulations methods and drug delivery. What struck me early on was the disconnect between drug discovery and real-world impact, that we can design and discover new molecules, but only a very small percentage of those drugs reach patients because they cannot be formulated into efficacious medicinal products. Looking back, that question largely shaped my interest in solubility-enabling technologies, which began with my MSc thesis on nano-sized drug delivery systems at the University of Greenwich. That was my first hands-on experience with the formulation and characterization of nanoparticles.
I then started my career in industry working in quality within the family business, which gave me a strong foundation in GMP principles and the realities of drug manufacturing. However, I quickly realized I wasn’t finished with R&D. This led me to pursue a PhD in the interdisciplinary lab of Prof. Ulrich Schubert at the University of Jena, where working with biodegradable polymers on nanoparticle systems shaped my understanding of how material design and formulation must come together to create viable drug delivery systems.
The end of my PhD coincided with the height of the Covid-19 pandemic, when there was an unprecedented urgency all over the world to come up with a solution to protect public health against this virus. The race was on to bring a vaccine to the market, and I joined CureVac as a process development scientist. I felt very fortunate to have the opportunity to work on something I found both scientifically fascinating and directly aligned with what I had been preparing for during my PhD. That year was an intense and invaluable learning experience. I saw first-hand what it takes to manufacture such complex therapeutics, while the industry itself was still learning how to produce mRNA–LNP vaccines at scale. Understanding those manufacturing challenges is what led me to LEON. At the time LEON was emerging as a small, innovative company focused on addressing manufacturing bottlenecks in nanoparticle-based drug products, including mRNA vaccines and therapies. Here, since joining in 2022, I’ve held different scientific roles, combining my background in formulation science and process development to help advance LEON’s technology platform to the market.
It feels like a privilege to be part of the wave of innovation that has been happening since the pandemic, and it has reinforced what motivates me, which is working at the interface of formulation science and manufacturing to translate science into real medicine.
NanoSphere: You have worked across early formulation, process development, and now lead particle science and formulation services for LNPs. Looking back, where do you see the biggest disconnect between how LNP formulations are designed at lab scale and how they need to behave as reliable, reproducible systems in late-stage development and manufacturing—and how should the field rethink this transition?
Blerina: One of the biggest disconnects I continue to see is the underestimation of how profoundly scale up will impact product quality. At lab scale, success is often defined by achieving acceptable particle size, PDI, or biological activity under controlled conditions. However, as development progresses toward late-stage manufacturing, those same formulations must behave as reliable, reproducible systems under significantly different process constraints. Too often, programs are not designed early enough through a true CMC lens.
LNPs are dynamic, multicomponent systems carrying a sensitive biological payload. They are inherently susceptible to shear stress, mixing conditions, and process-related impurities. Product quality in LNP-based therapies is therefore tightly coupled to the manufacturing process. Controlled mixing, scale-dependent effects, and process robustness directly shape critical quality attributes. While we now have a somewhat standardized manufacturing paradigm for mRNA vaccines, process robustness across scales remains a challenge.
At LEON, we’ve addressed the scalability challenge with our modular FR-JET® mixer, designed to preserve controlled mixing as processes move from R&D to GMP. Its adaptable geometry and flow configuration help reduce scale-related variability and support a smoother transition into manufacturing.
Another key issue is insufficient process understanding early in development. Biotech companies often prioritize urgent milestones to satisfy investors, which is understandable. However, failing to establish at least a roadmap for scale-up and commercial manufacturing can be costly later. A product that demonstrates functionality at lab scale may struggle in clinical or commercial settings if the relationship between process parameters and product quality is not well understood.
This challenge becomes even more evident as we move from large-scale production toward personalized therapies (n=1). In individualized treatments, the process largely determines product quality, and often whether manufacturing is feasible at all. Ex vivo therapies, for example, are extremely costly to produce, which is one of the reasons they are not prioritized as first- or second line treatments even when clinically compelling. In addition, long vein-to-vein times can cost patients valuable time in the course of their disease.
For in vivo RNA-based therapies, this requires rethinking manufacturing altogether. Instead of adapting large-scale processes to small-batch needs, we need fast, low-waste and cost-efficient GMP production that can operate closer to the point of care, without requiring massive infrastructure investments. At LEON, we anticipated this bottleneck and developed the NANOme® to enable small GMP batches in decentralized settings. The goal is to make the manufacturing of complex RNA-LNP therapies technically feasible and economically viable, ultimately improving access for patients.
Drug companies innovating in the space of mRNA need to rethink the transition by beginning with the end in mind. Manufacturability should be considered as early as proof-of-concept. Especially in cancer vaccines and personalized genetic medicine, the manufacturing process may ultimately determine whether a therapy reaches patients, not just whether it works biologically.
NanoSphere: Companies like leon-nanodrugs sit in a unique position: not developing the drug itself but enabling many developers to translate nano-enabled medicines. From this vantage point, what do you believe is missing in today’s nanomedicine ecosystem—skills, standards, shared language, or infrastructure—and what would have the greatest impact on patients if it were fixed? Where do you see regulators becoming more flexible—and where do you think the field underestimates regulatory risk?
Blerina: From our position as a technology innovator enabling drug developers, the most visible gap in today’s nanomedicine ecosystem is not as much in the science itself, but in the manufacturing technology surrounding it.
RNA-LNP science has evolved rapidly, yet the supporting process infrastructure has not matured at the same pace. Product quality is inseparable from the manufacturing process, and in complex therapies such as cancer vaccines and personalized genetic medicine, the process can ultimately determine whether a product reaches market approval. Many existing solutions were not designed to produce small, sterile batches efficiently, particularly at or near the point of care.
The industry still faces bottlenecks in controlled mixing, reproducibility across scales, operational complexity, and cost-efficient aseptic manufacturing. At LEON, we focused specifically on these challenges—enabling controlled mixing across scale and producing a sterile GMP batch in 20 minutes using our single-use plug-&-play system. The objective is not just technical feasibility, but simpler and more cost-efficient decentralized manufacturing.
Beyond manufacturing, analytical capability must continue to evolve. Advanced techniques such as AUC, SAXS, FFF-MALS, and emerging single-particle methods offer deeper structural insight, but they require further adaptation for these complex products as well as skilled expertise before becoming routine tools in development. Without stronger analytical foundations, it is difficult to build confident, phase-appropriate CMC strategies.
Lastly, regulatory clarity has also shown itself to be a challenge. Pre-pandemic and up until recently, guidance for nanoparticle-based products often relied on blanket frameworks, leaving developers to interpret expectations around characterization and process understanding. That landscape is now evolving. The EMA, MHRA, and FDA are actively developing frameworks for decentralized and advanced manufacturing for ATMPs. At LEON, we are aligning our NANOme® system proactively with these evolving guidelines so drug developers can adopt the technology with greater regulatory clarity and lower risk.
The greatest impact for patients will come from making these therapies manufacturable at the right scale. Innovation in delivery must be matched by innovation in how we make these medicines.
NanoSphere: If there’s one key message or insight you’d like to share with readers about the future of nanomedicine, what would it be?
Blerina: Precision nanomedicine will only advance as evolving science meets simpler, faster, more affordable manufacturing.