Development of a lateral flow strip assay improves quality control in mRNA vaccines, ensuring efficacy in low-resource settings.
The rapid adoption of mRNA‐based vaccines highlights the critical need for on‐site quality control (QC) methods, particularly in low‐income countries with decentralized manufacturing. Existing techniques, such as liquid chromatography‐mass spectrometry (LC‐MS) and capillary electrophoresis (CE), are resource‐intensive, requiring specialized equipment and expertise. To address this, a comprehensive lateral flow strip assay (LFSA) has been developed to evaluate key mRNA quality attributes—5' capping efficiency, integrity, and lipid nanoparticles (LNPs) encapsulation efficiency. Leveraging antibody‐labeled fluorescence nanoparticles and polydeoxythymidine oligonucleotide to simultaneously probe both 5' cap and poly(A) tail, the LFSA offers sequence‐independent, rapid (15 min), and sensitive mRNA analysis. Validation against standard methods demonstrates comparable accuracy while significantly reducing sample requirements and operational complexity. Moreover, the LFSA enables real‐time monitoring of mRNA stability under varying storage conditions and provides precise encapsulation assessments, distinguishing between intact and degraded mRNA in LNPs. This portable and cost‐effective platform bridges critical gaps in mRNA QC, streamlines manufacturing workflows, and ensures mRNA therapeutic efficacy in diverse applications.
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Luo et al. (2025) studied this question.
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