NIST Calls for Researchers to Test mRNA Research Grade Test Material

By Allison Proffitt 

September 18, 2025 | Last month, the National Institutes for Standards and Technology (NIST) released a new Messenger RNA Research Grade Test Material. The mRNA test material is available to researchers now who will participate in an interlaboratory study to determine the material’s fitness-for-purpose as an eventual reference standard or quality control material, providing data and feedback to NIST.   

mRNA is of particular interest to researchers because of its broad medical value including as vaccines or therapeutics targeting infectious diseases, cancers, and autoimmune diseases, as personalized treatments for genetic diseases, for protecting food and livestock, and more. “mRNA is one part of the future of therapeutics designed for treatment and prevention of respiratory diseases, cancers, and more,” explained Mark Lowenthal, a NIST research chemist, in an email interview with Bio-IT World.  

“Having an mRNA reference material can be useful to anchor the accuracy of analytical measurements that are required for assessing a drug substance/drug product’s efficacy and safety, and the reproducibility of the production lots, over time, and between labs,” he continued.  

The mRNA Research Grade Test Material is RGTM 10202 FLuc mRNA with each unit consisting of one vial with ≈25 µg of mRNA in of nuclease-free water, pH 6.4, frozen at -80o C.   

The RGTM will be assessed by NIST and participants in the interlaboratory study (ILS) for its fit-for-purpose utility to underpin analytical measurements of the critical quality attributes (CQAs) for mRNA drug substance. These include, but are not limited to, sequence identity, concentration, intactness, 5’ capping efficiency, 3’ poly(A) tail length, and product- and process-related impurities, as well as protein expression, safety, and other attributes.   

“If the material is determined to be useful, and the design is appropriate, we will request support and seek capabilities to produce this as a scaled-up material to be developed into [a Standard Reference Material],” Lowenthal said. “Changes can be made if appropriate going from RGTM to SRM in either the design, scale, or scope.”