Mixing in Milliseconds

Mixing is a crucial step in many industrial processes, even if it isn’t always visible. Whether in pharmaceutical and biotech production or in the chemical industry: The quality of mixing processes is critical in order to manufacture products efficiently and cost-effectively.

This is especially clear in the production of lipid nanoparticles, which are crucial in the formulation of mRNA-based active ingredients. These active ingredients  are sensitive and must be embedded in a lipid capsule so they reach the desired cells in the body. Even slight deviations in the mixture can determine whether a drug is stable and effective.

In practice, however, manufacturers encounter a problem that has remained unsolved for years: Microfluidic systems achieve excellent mixing quality, but are only suitable for tiny amounts of liquid. Conventional mixers, like T, Y, or impingement jet variants, achieve higher throughputs, but deliver significantly less homogeneous results. The conflict between quality and quantity makes it difficult to scale up from the laboratory to production.

Researchers at Fraunhofer IPK have been working on a new development in this area. Together with the  Berlin-based company FDX Fluid Dynamix GmbH, they developed FDmiX, a technology platform that combines short mixing times with high homogeneity while remaining scalable. It is designed to function reliably on a laboratory scale as well as in larger plants.

The technology meets the high-quality requirements of pharmaceutical research and the throughput requirements of industrial production. The platform is meant to show that the old conflict between mixing quality and production speed no longer has to be a trade-off. This is true whether for the development of new drug carriers, the production of nanoemulsions, or for continuous chemical reactions.

Efficiency through control

FDmiX uses a passive, oscillating nozzle, also known as an OsciJet nozzle, which has no moving parts. Targeted flow control mixes one of the two liquids at a high frequency, causing it to oscillate. The oscillating liquid then hits the second component vertically in the mixer, enabling homogeneous mixing in less than a millisecond.

The technology’s performance is impressively demonstrated in the encapsulation of mRNA in lipid nanoparticles. This has led to a significant reduction in particle size, ranging from 10 to 20 percent. This improvement could enhance the body’s transport of active ingredients and their uptake into cells. At the same time, the particles produced have a lower polydispersity index (PDI), indicating a more homogeneous particle distribution. This results in a significant improvement in particle stability, leading to better transportability and storability of the drugs. These findings demonstrate that FDmiX improves mixing processes and offers added value in terms of product quality and production reliability.

Annika Brehmer is the head of the Bio- and Pharmaceutical Production Technology department at Fraunhofer IPK. She recognizes the solution’s clear advantages, especially in early formulation development, where every resource is crucial. »FDmiX allows us to work precisely and reproducibly without expensive disposable accessories such as cartridges. This saves us time, materials, and budget. It makes research more economical and significantly accelerates the transition to scaled-up production.«

From formulation to series production

The FDmiX platform boasts a key advantage: complete scalability across the entire product life cycle, from early formulation development to robust large-scale production. The compact FDmiX XS variant allows for precise and economical determination of suitable formulations on a laboratory scale. Disposable cartridges become unnecessary, reducing the equipment needed. Research institutions and development departments will see lower operating costs, reproducible results, and rapid availability of test data.

Once a formulation is established, it can be transferred without modification to larger mixers in the FDmiX series – up to and including the FDmiX XL. The particle properties remain constant. Size, homogeneity, and encapsulation efficiency are comparable across scales. This means that the platform can be used for both initial screening and industrial series production, always with the same technological basis.

»FDmiX is more than a technically impressive mixing solution,« says Dr. Luiz Schweitzer, process technologies expert at Fraunhofer IPK. »The platform is tailored to the requirements of Good Manufacturing Practice (GMP) right from the start. For our partners, this means fewer adjustments, shorter validation times, and a faster transition to market-compliant production.«

This technology facilitates the transfer of R & D processes to industrial scale. It can be flexibly integrated into existing annexes of biotech and pharmaceutical companies. FDmiX is set to become a scalable core element of modern production systems, ensuring the reliable and gradual transfer of research developments into marketable products.

FDX Fluid Dynamix, based in Berlin, develops technologies for fluid mechanics. The focus is on an inconspicuous component that can have a big impact.

FDX Fluid Dynamix, founded in 2015 as a spin-off from the Technical University of Berlin, has brought the OsciJet nozzle to market maturity. Its operating principle is straightforward: A fluid flow is set into a controlled oscillation, which is transferred to the mixing process. This ensures uniform mixing in milliseconds, eliminating mechanical wear and maintaining high process reliability.

This technology has applications in numerous industries. In the pharmaceutical and biotech industries, the quality of mixing processes is crucial for the effectiveness of products. The technology’s versatility extends to various fields, including chemical industry, mechanical engineering, and energy and environmental technology. It is an essential solution for any application where efficient and controlled mixing is crucial.

FDX is the bridge between basic research and industrial application. The company offers individual nozzles and develops modular platform solutions that can be integrated into existing production systems. FDX strategically focuses on markets where process stability, scalability, and resource efficiency are paramount.

Today, a team of nine employees at the Berlin-Siemensstadt location is working to further develop the technology. Their approach is straightforward: translating complex physical flow phenomena into robust, easy-to-use products. With this self-image, FDX positions itself as a young technology company that aims to contribute to greater efficiency and sustainability in industrial processes through precise flow control.