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Updated: Jan 31, 2026

Testing the In Vitro and In Vivo Efficiency of mRNA-Lipid Nanoparticles Formulated by Microfluidic Mixing
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Concentration Approaches for mRNA and mRNA-LNP Formulations: Enabling mRNA Integrity Quantification in

Shang-Yin Wu1,2, Yun-Jie He3, Zhi-Jun Guo4

  • 1Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China.

Electrophoresis
|January 30, 2026
PubMed

Insights

New methods concentrate low-level RNA, including mRNA vaccines and self-amplifying mRNA (saRNA), improving stability assessment for RNA therapeutics. This enhances quality control for crucial nucleic acid-based medicines.

Area of Science:

  • Biotechnology
  • Molecular Biology
  • Pharmaceutical Sciences

Background:

  • mRNA and self-amplifying mRNA (saRNA) are crucial for disease prevention and treatment.
  • Accurate detection of low-concentration RNA, including mRNA-lipid nanoparticles (mRNA-LNPs), is vital for quality control of RNA therapeutics.
  • Current methods lack effective concentration strategies for labile, low-abundance RNA samples.

Purpose of the Study:

  • To develop and validate novel concentration methods for low-abundance RNA.
  • To enable precise assessment of RNA stability and integrity.
  • To improve quality control for mRNA-based therapeutics.

Main Methods:

  • Established two distinct RNA concentration techniques: freeze-drying and ultrafiltration.
  • Applied these methods to mRNA, mRNA-LNPs, and saRNA formulations.
  • Evaluated the stability and integrity of concentrated RNA using stability assessments and high-performance liquid chromatography.

Main Results:

  • Successfully concentrated dilute RNA solutions to high-concentration preparations.
  • Preserved the structural and molecular integrity of mRNA, mRNA-LNPs, and saRNA during concentration.
  • Demonstrated superior storage stability and practical applicability of the concentrated RNA products.

Conclusions:

  • Developed effective concentration strategies for low-abundance, labile RNA, including mRNA and saRNA.
  • Enhanced the accuracy and feasibility of RNA integrity assessment.
  • Provided a valuable tool for quality control of RNA-based therapeutics, addressing a critical limitation in the field.

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