![]() For example, I've now used this new setup to closely examine how very small plastic debris called nanoplastics, which pollute our waters, can be covered by binding proteins on their surface. "In addition to helping create new medicines, we can also use them to understand how different-sized particles interact in complex biological systems. "The combination of these two tools can now be used in many different areas of science," said Melissa Graewert, Staff Scientist at EMBL Hamburg. EMBL Hamburg's SAXS beamline at the PETRA III synchrotron, now equipped with the AF4 device-set up with the help of collaborators at Postnova Analytics GmbH-will open up new opportunities not only for studying pharmaceutical nanoparticles, but also for other types of research. SAXS is one of the key techniques applied and available at EMBL Hamburg as a service for researchers from academia and industry in Europe and beyond. To do this unequivocally, only one type of particle must be analyzed at a time, which is why combining sorting and measuring is so critical. SAXS allows scientists to determine the structure and the number of sorted particles. AF4 separates lipid-based nanoparticles from other parts of an mRNA nanomedicine and sorts them according to their size. What makes the new method so powerful is that it couples two techniques: asymmetrical-flow field-flow fractionation (AF4) and small-angle X-ray scattering (SAXS). The new method can be very useful in evaluating the quality of these generics in comparison to the originator products and will pave the way for further high-quality drug products at an even more reasonable cost." A two-in-one method "Now even generic liposome products are available on the market, and probably there will be more to come. "Liposomes are another type of pharmaceutical nanoparticles which have been applied for years for the treatment of cancer or infectious diseases such as fungal infections," said Peter Langguth, the project leader at Johannes Gutenberg University Mainz. The method will also be applicable for the investigation of other pharmaceutical products. This information can be handy to evaluate product quality." "With our new method, we can determine many size-related features all at once, with a single measurement and for all nanoparticles in a product. "So far, it was very difficult to measure all these size-related properties therefore, often only average values were determined," said Heinrich Haas, one of the leaders of the project. The work is published in the journal Scientific Reports. The study was conducted based on lipoplex formulations, an mRNA delivering technology developed by BioNTech. Scientists at EMBL Hamburg, Johannes Gutenberg University Mainz, Postnova Analytics GmbH, and BioNTech SE have developed a new method to precisely elucidate the size of all particles in such pharmaceutical products, as well as their structure and how many RNA molecules they carry inside them. It is therefore important to control the particle size inside a pharmaceutical product to evaluate and ensure its quality. The particle size can have an influence, for example, on the stability and the behavior of the formulations after administration. By their nature, nanoparticles can vary a little bit in size, some being a bit smaller, and some a bit larger than the average value. Their properties depend on composition, structure, manufacturing protocol, and other conditions.Īn important aspect of nanoparticles is their size. Lipid-based nanoparticles are tiny droplets of fat-like molecules that serve as protective packaging for the mRNA. One requirement for all applications of mRNA in pharmaceutical products is that they need to be formulated in suitable delivery systems, each designed for different functions and optimized for therapeutic product needs based on the intended application and route of delivery. Many novel mRNA nanomedicines, which are currently in different stages of development, may become available in the future. It could also transform the large field of interventions by therapeutic proteins. But mRNA's potential for pharmaceutical application is expected to go much beyond this-it could open up new opportunities for the treatment and prevention of diseases, such as viral and bacterial infections, cancer, cardiovascular diseases, and inflammatory and auto-immune diseases. Messenger RNA (mRNA) nanomedicines, a ground-breaking technology that has led to the development of the first approved COVID-19 vaccine, was recently recognized by the Nobel Prize in Medicine or Physiology.
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