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<p>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.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月18日

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  • Jason Pennucci,
  • Amanda Hays,
  • Wendy Adamowicz,
  • Mitra Azadeh,
  • Mohamed Benhammadi,
  • Enric Bertran Portabella,
  • MingLai Cheng,
  • Kelly Colletti,
  • Sanjay L. Dholakiya,
  • Rajitha Doddareddy,
  • Lara Duchstein,
  • Jennifer Durham,
  • Sebastian Guelman,
  • Bryan Gullick,
  • Kate Herr,
  • Darshana Jani,
  • Niketa Jani,
  • Oskar Johansson,
  • Kaarthik John,
  • Mikael Kubista,
  • Amy Lavelle,
  • Geng Li,
  • Yanchun Li,
  • Hsing-Yin Liu,
  • Timothy Lochmann,
  • Haiyan Ma,
  • Benjamin Moritz,
  • Jacqueline Murphy,
  • Alice Park,
  • Suresh Peddigari,
  • Marie-Soleil Piche,
  • Swarna Suba Ramaswamy,
  • Asha Reddy,
  • Muriel Smet,
  • Johannes Stanta,
  • Jenny Valentine,
  • Katherine Veirs,
  • Venkata Vepachedu,
  • Mark Wissel,
  • Meizhen Wu,
  • Bin Xu,
  • Susan Zondlo

摘要

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.

Graphical Abstract