A new CEN Workshop is being planned which will complement the activities of the EU Research project ETERNAL. The mission of this project is to contribute to the safe and sustainable development of pharmaceutical manufacture, use and disposal.
The encapsulation of RNA and DNA in lipid nanoparticles (LNPs) is an important emerging technology in the delivery of genetic materials for therapeutic applications. However, accurate determination of encapsulation efficiency remains challenging, and other traditional methods such as gel electrophoresis and UV spectroscopy offer present limitations.
The proposed Workshop aims to meet this need by establishing a standardized method for determining the encapsulation efficiency of RNA and DNA in LNPs using fluorometry. The approach provided by this Workshop leverages fluorescence-based detection for higher sensitivity and specificity, which offers a clear distinction between encapsulated and free nucleic acids.
The resulting CWA will be applicable to manufacturers of lipid nanoparticles in academia and industry. The results will form a valuable basis for design for pharmaceutical and biotechnology companies. It will allow these companies to consider nucleic acid encapsulation efficiency in the early design phases and hence develop more effective and reliable delivery systems. The subject of the planned CWA is not currently covered by any existing standard or Technical Committee.
The kick-off meeting for the Workshop will take place remotely via Microsoft Teams on 4th June 2025 from 10.00 a.m. to 12.00 p.m. (CEST). To attend, please email the Workshop Secretary to register your interest (tsanchez@une.org).
All interested parties are invited to submit comments on the draft Project Plan using the commenting form below, to the Workshop Secretary, Teresa Sanchez Segura (UNE) (tsanchez@une.org).
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