New Mixer Tech Aims to Shatter mRNA Manufacturing Bottlenecks

PLANEGG, Germany – January 09, 2026 – A newly published peer-reviewed study has validated a technology that could significantly dismantle critical barriers in the production of mRNA therapies, potentially accelerating the delivery of next-generation medicines for cancer, rare diseases, and future vaccines. The study, appearing in the high-impact journal Pharmaceutics, demonstrates that a novel mixing system developed by German pharmatech company leon-nanodrugs GmbH enables the creation of highly concentrated and more potent drug delivery vehicles, addressing a major operational bottleneck that has challenged the biopharmaceutical industry.

The Nanoparticle Production Problem

The success of mRNA vaccines for COVID-19 hinged on a critical delivery technology: lipid nanoparticles (LNPs). These microscopic fatty spheres act as protective shuttles, safely delivering fragile mRNA molecules to their target cells in the body. However, as the industry looks to expand mRNA applications, the complex and often inefficient process of manufacturing these LNPs has become a significant hurdle.

For years, developers have grappled with major challenges in scaling up LNP production from small lab batches to commercial volumes. Traditional methods, including certain microfluidic mixers, are prized for their precision but are often plagued by issues like channel clogging, low throughput, and difficulties in scaling up without compromising product quality. Conventional T-mixers, another common tool, can suffer from inconsistent reproducibility, complicating manufacturing and regulatory compliance.

A major consequence of these limitations is that LNP formulations are often produced at low concentrations. This means large volumes of liquid, primarily water and organic solvents, are required to produce a relatively small amount of active product. This dilute mixture must then undergo an extensive and time-consuming downstream process, typically involving Tangential Flow Filtration (TFF), to concentrate the nanoparticles and remove solvents. This multi-step process not only adds significant time and cost but can also introduce stress on the delicate nanoparticles, potentially affecting their stability and effectiveness.

A Validated Leap in Formulation Science

The new study provides robust evidence that LEON's FR-JET® modular mixer technology directly confronts these long-standing issues. The research, led by Dr. Blerina Shkodra, a scientist with experience in the development of the CureVac mRNA vaccine, shows that the system can produce stable LNPs at lipid mixture concentrations exceeding 50 mg/mL. This figure is significantly higher than concentrations typically reported using conventional methods, representing a major step forward in process intensification.

“There is growing recognition across the industry that LNP manufacturing challenges are not solely scientific, but are also largely operational in nature,” said Dr. Shkodra, the study's lead author. “Using LEON’s FR-JET® technology, we show that LNPs can be formulated at lipid mixture concentrations above 50 mg/mL, not only retaining product quality but also enhancing potency in vivo.”

By starting with a much more concentrated mixture, manufacturers can potentially shorten or even eliminate the initial, rate-limiting ultrafiltration step of TFF. This could drastically reduce overall process time, cut down on the consumption of expensive buffers, and simplify the entire manufacturing workflow. The technology’s robust, jet-based mixing principle avoids the narrow channels prone to clogging, enabling a predictable and direct path from small-scale development to large-scale GMP manufacturing.

The study's findings were supported by advanced imaging. Cryogenic transmission electron microscopy (Cryo-TEM) revealed that the high-concentration process produces more uniform, solid-core particles. This improved morphology is linked to greater product quality and stability, with the LNPs demonstrating colloidal stability for three to six months in different buffer systems—a crucial factor for drug shelf-life and supply chain logistics.

Redefining Potency and Patient Impact

Beyond manufacturing efficiencies, the research indicates that the method of production directly influences the therapeutic effectiveness of the final product. The study demonstrated that the highly concentrated mRNA-LNPs produced with the FR-JET® system exhibited enhanced in vivo activity, meaning they performed better when tested in a living organism.

This enhanced potency has profound implications for patient care. A more potent drug could allow for lower doses to achieve the desired therapeutic effect, which may in turn lead to improved tolerability and fewer side effects for patients. For complex diseases like cancer, where therapies often involve multiple rounds of treatment, a more efficient and better-tolerated delivery system could be transformative.

This breakthrough opens the door for a wider range of mRNA applications. While vaccines have been the technology's most visible success, researchers are actively developing mRNA-based treatments for genetic disorders, autoimmune diseases, and personalized oncology. The ability to manufacture these advanced therapies more efficiently and with potentially greater efficacy could lower development costs and accelerate their journey from the laboratory to the clinic, ultimately expanding patient access to these cutting-edge treatments.

A New Paradigm for Scalable Medicine

The validation of the FR-JET® technology signals a potential shift in the manufacturing paradigm for advanced therapies. By enabling smoother translation from early-stage formulation screening to commercial-scale production, it offers a more robust and predictable pathway for drug developers. Leon-nanodrugs supports this entire workflow with a portfolio of systems, from its NANOscreen® for initial development to its NANOus® for GMP manufacturing, all built on the same core technology.

This integrated approach is designed to help pharmaceutical companies, small biotech firms, and contract development and manufacturing organizations (CDMOs) de-risk their development programs and accelerate timelines. As the industry moves toward more personalized and complex medicines, such flexible and scalable manufacturing platforms will become increasingly critical.

The significance of the findings was underscored by the company’s leadership. “This peer-reviewed study validates the science behind the FR-JET® technology and confirms that our commercially available manufacturing systems are making a big difference,” said Dr. Wolfgang Hofmann, CEO of LEON. Looking ahead, he hinted at further innovations, stating, “It marks the beginning of a new phase for LNP manufacturing, and it paves the way for what LEON has prepared to deliver in 2026.” This forward-looking statement suggests the company sees this validated breakthrough not as a final destination, but as a foundational step toward further advancements in the rapidly evolving field of nanomedicine.