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- A new NIST Research-Grade Test Material, RGTM 10202 FLuc mRNA, has been released to support mRNA therapeutics.
- RGTM 10202 FLuc mRNA will be assessed during an interlaboratory study (ILS) to determine the fitness-for-purpose as a reference standard or as a quality control material.
Messenger RNA (mRNA)-based therapies require a careful assessment of Critical Quality Attributes (CQAs) using various analytical techniques, to ensure consistency and safety of a drug substance. Reference materials are key to achieving consistent measurements. Potential uses of mRNA in healthcare are considerable, 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 commonly packaged as a drug substance (DS), encapsulated within a lipid nanoparticle (LNP) vesicle for delivery to a target tissue and subsequent translation into an intentional protein product. LNP-mRNA was successfully demonstrated in vaccines developed during the COVID pandemic and are approved by regulators at the U.S. FDA, Europe’s EMA, Health Canada, and the MHRA.
RGTM 10202 FLuc mRNA is a newly developed NIST Research-Grade Test Material with each unit consisting of one vial with ≈ 25 µg of mRNA in of nuclease-free water, pH 6.4, frozen at –80 oC. This RGTM will be assessed during an interlaboratory study (ILS) to determine the fitness-for-purpose as a reference standard or as a quality control material of the commonly accepted CQAs for mRNA DS, including but 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. The ILS aims to identify potential sources of variability in analytical techniques, to establish a harmonized definition of the measurand between analytical techniques for each attribute, and to establish an mRNA design that may be useful for future scale-up production into a NIST Standard Reference Material. This ILS seeks to include data and results from established technologies, as well as advanced techniques that are demonstrated to be robust and reproducible, to compare between techniques and labs, and to identify technology gaps.
For more information about the RGTM, or to participate in the interlaboratory study, please contact Mark Lowenthal.
