PLANEGG, Germany and MUNICH, Jan. 09, 2026 — A new study published in Pharmaceutics () demonstrates that LEON’s FR-JET® modular mixer addresses significant manufacturing challenges by enabling the production of highly concentrated lipid nanoparticles (LNPs). The research indicates that formulating LNPs at lipid mixture concentrations substantially higher than currently reported in scientific literature and industry sources can lead to improved biological function in vivo, streamlined manufacturing processes, and enhanced storage stability.
Overcoming the bottleneck
“The industry increasingly recognizes that LNP manufacturing challenges are not solely scientific but are also largely operational in nature,” stated Dr. Blerina Shkodra, the study’s lead author. “Our findings using LEON’s FR-JET® technology show that LNPs can be formulated at lipid mixture concentrations exceeding 50 mg/mL, not only maintaining product quality but also boosting potency in vivo. These results suggest a practical pathway toward simplified manufacturing and increased throughput, allowing drug innovators to deliver life-saving mRNA therapies to patients more rapidly and efficiently.”
Traditional microfluidic mixers often face limitations such as clogging, insufficient robustness, and scalability issues. Conventional T-mixers, on the other hand, can suffer from inconsistent reproducibility, which frequently complicates manufacturing when employing scale-out strategies. In contrast, LEON’s FR-JET® modular mixer provides robust mixing, facilitating process intensification while supporting predictable and direct scale-up.
The advantages of formulation at significantly higher lipid mixture concentrations for LNP developers include:
Manufacturability – process intensification: Manufacturing with higher starting material concentrations can reduce or even eliminate the initial rate-limiting ultrafiltration step in tangential flow filtration (TFF), thereby shortening overall downstream process time and decreasing buffer consumption during diafiltration.
Product Performance – potency and dosing: Cryogenic transmission electron microscopy (Cryo-TEM) revealed more uniform, solid-core particles. Increased lipid and RNA concentrations can enhance in vivo potency, potentially leading to improved tolerability and more effective dosing strategies.
Product Quality – morphology and stability: Higher solid-core fractions indicate more consistent particle morphologies, coupled with demonstrated colloidal stability for 3 to 6 months in two distinct buffer systems.
CMC Scalability – development to manufacturing: This approach supports a smoother transition from formulation development to manufacturing scale, enabling more robust processes and facilitating easier technology transfer.
“This peer-reviewed study validates the scientific principles behind the FR-JET® technology and confirms the significant impact of our commercially available manufacturing systems,” said Dr. Wolfgang Hofmann, CEO of LEON. “This marks the commencement of a new era for LNP manufacturing and paves the way for what LEON has prepared for delivery in 2026.”
ABOUT LEON (leon-nanodrugs GmbH)
Based in Planegg/Munich, leon-nanodrugs GmbH is a Pharmatech company specializing in the development and commercialization of equipment for encapsulating genetic material and other pharmaceutical active substances into nanoparticles, such as lipid nanoparticles (LNPs). The company utilizes its proprietary FR-JET® technology to create innovative solutions. Its equipment range includes NANOscreen® for formulation screening, NANOlab® for process development, and NANOme® and NANOus® for GMP manufacturing. These systems are designed for both individualized scales and commercial production, and the company also offers formulation and process development services to its clients. LEON’s platform is intended to empower pharmaceutical companies, small biotech firms, research institutions, and CDMOs to leverage advancements in advanced therapies.
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