Skip to main content
CRS 2026 Annual Meeting & Exposition Main banner

Manufacturing and Process Scale-Up

Rapid Optimization and Scale-Up of PBAE-Based siRNA Delivery via DoE-Guided Microfluidics

Adrian Kromer – PhD, LMU Munich; Olivia Merkel – Professor, LMU Munich
Introduction:

Microfluidic technology in nanomedicines has significantly expanded the use of delivery systems in clinical applications, yet microfluidic manufacturing of polymeric nanoparticles has not yet caught the same interest in the scientific community and major challenges including transferability remain [1,2]. Here, a well-established Poly (β-aminoester) (PBAE) polymer for siRNA delivery was applied as a case study [4]. This study establishes a robust and scalable QbD-guided workflow for the development of microfluidically manufactured siRNA nanoparticles, enabling rapid optimization, reliable scale-up, and clinically relevant performance.

Learning Objectives:

  • Identify optimal PBAE–siRNA formulations using Design of Experiment (DoE)-guided microfluidic screening
  • Assess scalability and transferability of critical process parameters (CPP) from lab-scale to scale-up production
  • Explain how polymer type, N/P ratio and flow settings shape nanoparticle properties and gene-silencing performance