PDA Ireland 2025: Science, Technology & Compliance

Listen to our talk

Speaker: Rok Sekirnik, Head Process Development mRNA | pDNA, Sartorius BIA Separations
Time and Date: Thursday, November 27, 2025 | 9:50 AM – 10:15 AM
Title:  Quality-by-Design in mRNA: Process Development and Manufacturing

Location: Clontarf Castle, Dublin

Join us!

Presentation abstract:

mRNA and other RNA-based therapeutic modalities (saRNA, tRNA, circRNA) are redefining the frontiers of modern medicine. Rok will explore how Quality-by-Design (QbD) principles can transform in vitro transcription (IVT) processes – from optimising yield and cost efficiency to ensuring superior product quality.

Expect insights into:

• Data-driven optimisation using Design of Experiments (DOE)
• Achieving IVT yields up to 25 g/L and transitioning from batch to fed-batch modes
• Minimising dsRNA formation, a critical quality attribute in mRNA products
• Advanced purification strategies using affinity and polishing chromatography