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mRNA: Removing Bottlenecks in Process Development and Manufacturing

Event: mRNA-Based Therapeutics Summit Europe

Date: January 2022

Presenter: Rok Sekirnik, Head of Process development for mRNA and pDNA


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:

  1. mRNA manufacturing is not yet a platform approach. Standardized products along the processes are needed
  2. mRNA is a relatively large molecule, which leads more challenges for downstream purification.
  3. mRNA is intrinsically unstable and prone to degradation.
  4. 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.