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Manufacturing and Process Scale-Up

Scalable mRNA-LNP Manufacturing Enabled by Microfluidic In-Line Dilution Across Development and Production Scale

Sanghun Lee – Principal process engineer, Inventage lab; Chan Hee Chon – CTO, Inventage lab; Jung Min Oh – Director, Inventage lab; Joo Young Cha – Director, Inventage lab; Donghoon Kim – Senior VP, Inventage lab; Ju Hee Kim – CEO, Inventage lab
Introduction: Lipid nanoparticles (LNPs) have emerged as a pivotal delivery platform for genomic medicines, yet conventional downstream processing methods, such as dialysis and ultracentrifugation, limit scalability. To ensure a seamless transition to manufacturing, scalability must be evaluated from early development. The Inventage Lab (IVL)-GeneFluidic® platform addresses these challenges through a microfluidic in-line dilution process that controls solvent exchange kinetics during LNP self-assembly. This study evaluates whether controlled mixing and dilution enables LNP manufacturing while preserving physicochemical and biological consistency from laboratory to commercial production.

Learning Objectives:

  • Participants will learn how controlled mixing influences LNP self-assembly during microfluidic manufacturing.
  • Participants will evaluate factors enabling scale-independent LNP production across R&D and manufacturing scale.
  • Participants will explain how in-line dilution strategies improve consistency and yield in LNP manufacturing.