ASTM International has approved a new standard (E3482) to characterise ribonucleic acids (RNA) in lipid nanoparticle (LNP) formulations, which 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, precompetitive analytical methods to characterise 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 organisations.”
“This new ASTM standard guide describes a series of options to help companies characterise 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 to test and analyse the RNA in RNA-LNP medicines, which helps to ensure that final products are consistent and of the highest quality.”
Nelson adds that by using industry vetted, precompetitive analytical methods, developers of RNA-LNP products can better understand the characteristics of their formulations, optimise their manufacturing processes and improve product quality.
This effort directly relates to the United Nations Sustainable Development Goal #3 on good health and well-being.