Explore the technical considerations for developing and validating pharmacokinetic assays for lipid nanoparticle (LNP)-mRNA drug products using RT-qPCR.

This white paper from Eurofins Viracor BioPharma and industry collaborators examines the unique bioanalytical challenges associated with measuring mRNA therapeutics in circulation. The publication provides practical guidance for assay design, validation, sample handling, and data interpretation to support the pharmacokinetic evaluation of emerging LNP-mRNA therapeutics.

Key topics include:

• The unique pharmacokinetic considerations of LNP-mRNA drug products
• RT-qPCR assay design strategies, including primer/probe design and multiplexing approaches
• Sample collection, processing, and stability considerations for preserving mRNA integrity
• Calibration curve, quality control, and method validation recommendations for regulated assays
• Technical considerations for extraction methods, sensitivity, specificity, and assay robustness
• The complementary role of RT-dPCR in supporting low-level mRNA quantification and pharmacokinetic assessments

As RNA-based therapeutics continue to expand across drug development pipelines, robust and scientifically sound bioanalytical strategies are essential for accurately characterizing pharmacokinetics and supporting the successful development of LNP-mRNA therapies.