Christian Dubiella, Global Program Manager at CDMO (WACKER)
Christian Dubiella, Global Program Manager at CDMO (WACKER)
Christian Dubiella, Global Program Manager at CDMO (WACKER)
Biography
Dr. Christian Dubiella is a seasoned drug development specialist with more than a decade of experience spanning early discovery and preclinical development in both academia and industry. Over the course of his career, he has worked across diverse therapeutic modalities, from inhibitor-based drug discovery to RNA/LNP-based nanomedicines.
He currently serves as Global Program Manager at WACKER (CDMO), where he leads a global CRO service model that helps translate early-stage innovation into GMP-stage development by bringing together business development, project leadership, and cross-functional collaboration. Earlier roles at WACKER and Leon-Nanodrugs gave him deep hands-on experience in RNA/LNP product development, formulation strategy, and manufacturing workflows.
His scientific foundation includes postdoctoral research at the Weizmann Institute of Science in Israel and a doctorate in chemistry from TU Munich. He is also an inventor, published author, and active contributor to Munich’s advanced therapies ecosystem, including through initiatives such as CNATM and as co-founder and organizer of the Advanced Therapies Stammtisch Munich.
Interview
NanoSphere: Tell us a bit about yourself—your background, journey, and what led you to where you are today.
Christian: Before we begin, I’d like to note that the views I share today are entirely my own. I’ve been fascinated by creating medicines since childhood, and studying chemistry at TU Munich felt, at the time, like arguably the most literal route into “making” drugs. That conviction deepened during my PhD in organic chemistry and X-ray crystallography, where the seeing-is-believing power of structural biology first made drug discovery feel truly real to me: seeing a molecule I had designed and synthesized resolved in electron density and bound to the anticancer target proteasome.
That perspective matured further during my postdoc at the Weizmann Institute of Science in Israel. As part of a broader collaboration with Harvard Medical School and Dana-Farber Cancer Institute, we advanced our Pin1 inhibitor Sulfopin from structural insight to biological impact, ultimately demonstrating a survival benefit in vivo in cancer models. Seeing that first Kaplan-Meier plot, and later seeing Sulfopin become commercially available as preclinical candidate through Merck/Sigma-Aldrich, left a lasting impression on me.
By then, I realized I had a generalist mindset and was becoming increasingly modality-agnostic. Leon-Nanodrugs laid the foundation for working hands-on with nanomedicines, and at WACKER as CDMO brought me even closer to the real-world application of medicines. Today, I lead a global CRO service model at WACKER, working at the intersection of science, strategy, and commercial execution to help early innovators move promising therapies toward GMP-stage development.
NanoSphere: In nanoparticle-based RNA delivery, efficacy is often the headline metric. From your experience, what are the less visible—but ultimately decisive—design parameters (stability, manufacturability, batch-to-batch variability, regulatory acceptability) that most frequently determine whether a formulation ever reaches patients?
Christian: Very relevant question. Working at a CDMO, I naturally have a strong awareness of scalability and manufacturability, but having seen a wide range of RNA/LNP product programs, I fully agree that over-focusing on efficacy alone can create challenges later in development.
To be clear, every RNA/LNP product developer should aim to optimize all aspects of a product for efficacy. Maximizing protein expression through mRNA design, such as optimizing UTRs and poly(A) tail length, together with choosing highly transfecting formulations is essential. However, I strongly believe this ambition must be paired with a fail-fast mindset and continuous consideration of GMP manufacturability.
In practice, this means deliberately challenging candidates early. I would apply forced stress conditions such as freeze–thaw cycling to anticipate behavior during downstream processing steps like TFF concentration. For example, a formulation with low PEG-lipid content may transfect very well but lack sufficient colloidal stability during concentration. Well-designed formulations should also tolerate high total lipid concentrations, particularly since cholesterol solubility in ethanol often becomes the limiting factor, and unnecessarily large process volumes are undesirable in GMP production. Broad buffer compatibility is often another indicator of robustness, as is high total flow rates and switching mixing technologies, such as microfluidics versus turbulent mixing, to define the true window of scalability and manufacturability.
When combined with a proportionally expanded analytical panel, this approach not only accelerates development decisions but also strengthens regulatory acceptability by building deeper process understanding. Ultimately, CMC considerations can outweigh purely efficacy-driven decisions when GMP availability, cost, or licensing constraints come into play. Striving for the best-performing product is the right ambition, but integrating operational realities early enables smoother development and more robust outcomes.
NanoSphere: What are the biggest bottlenecks companies face when moving mRNA/LNP candidates toward GMP manufacturing?
Christian: I would distinguish between external bottlenecks, which affect the field as a whole, and internal bottlenecks, which are more company-specific.
A classic external bottleneck is the limited availability of GMP-grade lipids and the licensing models attached to them. Innovation in the RNA/LNP space is often driven by startups and emerging biotechs, yet many struggle to meet the commercial expectations of lipid and formulation suppliers. These licensing models frequently involve substantial upfront fees, six-figure milestone payments tied to clinical progression, and downstream royalties. While I fully agree that lipids are more than simple excipients, such models are often unsustainable for early innovators and can significantly restrict access to critical materials.
On the internal side, many companies are strong either in payload design or in formulation development, but rarely in both, which makes external expertise essential to close the gap. In addition, scalability, manufacturability, and regulatory expectations are often underestimated early on. Regulatory guidelines are too often treated as blueprints, rather than as a framework that still requires a deep understanding of the process and its critical parameters. Without that perspective, companies can face major delays when transitioning toward GMP manufacturing.
Overall, overcoming these bottlenecks requires both structural changes across the ecosystem and earlier, more integrated CMC thinking within companies, ideally supported by external expertise at an early stage.
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?
Christian: It’s often said that only a tiny fraction of RNA therapeutics ultimately makes it out of the endosome and into the cytoplasm, which makes the success of today’s RNA/LNP medicines all the more remarkable. To me, that is exactly what makes this space so inspiring: we are already seeing transformative medicines from a technology that is still far from its full potential. I am convinced that as we remove the bottlenecks that still limit effective RNA/LNP delivery, from endosomal escape to access to GMP-grade lipids, and from manufacturability to quality and regulatory readiness, the impact of these medicines will expand dramatically.
If you have the chance to be part of this revolution, dream big: think indication-first, across modalities, embrace complexity, and translate it into simplicity, without losing sight of CMC realities.
Christian's references
Advanced Therapies Stammtisch Munich: https://www.linkedin.com/groups/10047485