mRNA: Removing Bottlenecks in Process Development and Manufacturing

Speaker:
Rok Sekirnik, Head of Process development for mRNA|pDNA, Sartorius BIA Separations

Abstract:

In vitro-transcribed messenger RNA-based therapeutics represent a relatively novel and highly efficient class of drugs. Current clinical efforts encompassing mRNA – based drugs are directed to three categories: mRNA vaccine, mRNA therapy and protein replacement therapy. As mRNA vaccine became the front runner to fight the COVID-19 pandemic, challenges surrounding their process development and manufacturing became readily apparent:

  • mRNA manufacturing is not yet a platform approach. Standardized products along the processes are needed
  • mRNA is a relatively large molecule, which leads more challenges for downstream purification.
  • mRNA is intrinsically unstable and prone to degradation.
  • High raw material cost is limiting mRNA commercialization.

This presentation provides a detailed overview of current mRNA manufacturing approaches, highlights challenges and recent successes, and offers perspectives on the future of mRNA manufacturing.

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