The new guide offers optimal methods to improve analysis and quality of RNA-based therapeutics.
Aug 06, 2025
ASTM International has approved a new standard (E3482) for characterizing ribonucleic acids (RNA) in lipid nanoparticle (LNP) formulations that is a significant advancement for the field of RNA therapeutics and drug delivery.
The new standard was developed by the nano-enabled medical products subcommittee (E56.08), part of ASTM’s nanotechnology committee (E56).
According to ASTM member Bryant C. Nelson, the standard provides industry-vetted, pre-competitive analytical methods for characterizing the encapsulation, extraction, and analysis of RNA in LNP formulations. According to Nelson, “this allows laboratories to use widely accepted and suitable methods, reducing variability and improving comparability across different labs and organizations.”
“This new ASTM standard guide describes a series of options to help companies characterize medicines that use tiny particles called lipid nanoparticles (LNPs) to deliver RNA (a type of genetic material) to the body,” says Nelson, staff research chemist at the National Institute of Standards and Technology (NIST). “The standard describes optimal methods for testing and analyzing the RNA in RNA-LNP medicines, which helps ensure that final products are consistent and of the highest quality.”
Nelson adds that by using industry-vetted, pre-competitive analytical methods, developers of RNA-LNP products can better understand the characteristics of their formulations, optimize their manufacturing processes, and improve product quality.
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September / October 2025
