EMBL Hamburg, in collaboration with Johannes Gutenberg University Mainz, Postnova Analytics GmbH, and BioNTech SE, has pioneered a groundbreaking method that sheds light on the intricacies of mRNA pharmaceuticals and other nanomedicines, potentially reshaping the development of novel products.
The advent of mRNA nanomedicines has been revolutionary, notably leading to the inception of the first authorized COVID-19 vaccine—a feat acknowledged by the Nobel Prize in Medicine or Physiology. However, the prospects of mRNA extend far beyond this milestone, holding promise for diverse applications in combating diseases such as viral and bacterial infections, cancer, cardiovascular ailments, and inflammatory conditions. Moreover, it has the potential to revolutionize therapeutic interventions involving proteins.
A multitude of novel mRNA nanomedicines, currently in various stages of development, herald a promising future. However, their utilization in pharmaceutical products necessitates suitable delivery systems tailored to diverse therapeutic needs, application routes, and intended functions.
Lipid-based nanoparticles act as protective carriers for mRNA, playing a critical role in their stability and behaviour post-administration. The size of these nanoparticles is a pivotal aspect influencing their properties, affecting stability and formulation behaviour.
The scientists at EMBL Hamburg, in collaboration with other institutions, have devised an innovative method to precisely gauge the size, structure, and RNA molecule content of particles within pharmaceutical products, specifically lipoplex formulations developed by BioNTech. This breakthrough study, published in Scientific Reports, empowers a comprehensive assessment of particle-related features in pharmaceutical products in a single measurement, a task previously challenging to achieve. Heinrich Haas, a project leader, emphasizes the significance of this novel method in evaluating product quality, enabling the determination of diverse size-related properties crucial for assessing pharmaceuticals’ integrity.
Peter Langguth, a project leader at Johannes Gutenberg University Mainz, underlines the method’s applicability in evaluating the quality of liposome-based pharmaceuticals, essential in the treatment of conditions like cancer and infectious diseases. This powerful new method combines asymmetrical-flow field-flow fractionation (AF4) and small-angle X-ray scattering (SAXS). AF4 segregates lipid-based nanoparticles based on size, while SAXS elucidates their structure and quantity, ensuring a meticulous analysis of individual particle types.
This pioneering work, a result of collaborative efforts, builds upon previous studies, delving deeper into mRNA formulations and delivery mechanisms. The research team continues to explore the vast potential of mRNA nanomedicines in collaborative endeavors.
