Technical Considerations of Pharmacokinetic Assays for LNP‑mRNA Drug Products by RT‑qPCR

As mRNA-based therapeutics continue to expand, accurate pharmacokinetic (PK) assessment is critical for understanding their behavior in circulation. This AAPS Journal white paper outlines key technical and regulatory considerations for developing and validating reverse transcription quantitative PCR (RT-qPCR) assays to support PK analysis of lipid nanoparticle (LNP)-mRNA drug products. The publication provides scientific guidance to promote consistency, reliability, and regulatory readiness across molecular bioanalytical workflows.