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Abstract
A workflow using capillary gel electrophoresis (CGE) for characterizing the poly(A) tail length of mRNA demonstrated resolution comparable to liquid chromatography coupled with mass spectrometry (LC-MS).
- The poly(A) tail length affects the stability and translation efficiency of mRNA, making it a critical quality attribute of mRNA therapeutics.
- Current methods like ion-pair reversed-phase liquid chromatography (IPRP-LC) can quantify mRNA with poly(A) tails but do not provide length information.
- High-resolution techniques such as LC-MS and next generation sequencing (NGS) can determine poly(A) tail length but are complex for routine release testing.
- The CGE method allows for quantification of each poly(A) length and provides relevant information for monitoring the quality of mRNA.
- This CGE method could serve as a suitable release testing approach for assessing poly(A) tail length in mRNA-based products.
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