FormuTech Summit 2025: mRNA Process Development & Manufacturing | LNP Formulations

Join our presentation:
cGMP Manufacturing From pDNA to LNP With Multiple Payloads

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA Separations

Abstract

• Typical mRNA/pDNA/LNP production process involves four key steps (All should meet cGMP criteria):
  • 1) plasmid DNA (pDNA, minicircle DNA) expression in E.coli, linearization for the mRNA, and pDNA purification
  • 2) in-vitro transcription (IVT) reaction
  • 3) mRNA purification
  • 4) nucleic acid(s) encapsulation and purification.
• High purity of raw materials and in-process control of the IVT process allow for high transcription number, much purer mRNA and lower consumption of expensive reagents.
• New analytical method to characterise the LNP with multiple payloads, including the LNP heterogeneity determination and lapidated RNA amount, will be presented.

Location: Milan, Italy