Lipid nanoparticle-messenger RNA (LNP-mRNA) drug products are a growing class of drug modalities. The unique composition of these drug products requires multiple measurements to account for the different components of these drug modalities. Pharmacokinetic (PK) measurements include measurement of the encapsulated mRNA and components of the LNP in circulation to understand the effectiveness of the therapeutic mRNA. The PK measurements can utilize many different platforms including PCR. Current regulatory guidance documents for bioanalytical method validation are specific to ligand binding and chromatographic assay methods and difficult to interpret for use with molecular workflows. The purpose of this paper is to provide information on considerations for validation of regulated reverse transcription quantitative PCR (RT-qPCR) assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.

• Keywords
• LNP, MRNA, PK, RT-dPCR, RT-qPCR,
• MeSH
• Real-Time Polymerase Chain Reaction * methods   MeSH
• Humans MeSH
• Lipids * chemistry   pharmacokinetics   MeSH
• Liposomes MeSH
• RNA, Messenger * pharmacokinetics   administration & dosage   MeSH
• Nanoparticles * chemistry   MeSH
• Reverse Transcriptase Polymerase Chain Reaction * methods   MeSH
• Animals MeSH
• Check Tag
• Humans MeSH
• Animals MeSH
• Publication type
• Journal Article MeSH
• Names of Substances
• Lipid Nanoparticles MeSH Browser
• Lipids * MeSH
• Liposomes MeSH
• RNA, Messenger * MeSH