The potential of therapeutic mRNA — and how to measure it

Abstract Messenger RNA (mRNA) has become a powerful new drug class for targeting cancer or infectious diseases. Therapeutic mRNA can be manufactured quickly and in large amounts by in vitro transcription. To ensure the quality of this drug substance, different parameters (e.g. integrity, 5’-cap, and identity) need to be assessed. For this purpose, different devices and techniques are employed in quality control (QC) laboratories. Any technique that is able to cover multiple parameters as a platform method would facilitate release testing in QC laboratories. On this basis, potentials and challenges of the Oxford Nanopore QC test for mRNA vaccines are discussed.  Biography Andreas Czech is Director in the Analytical Development Department at BioNTech SE. His team develops molecular biological assays to assess the quality of therapeutic RNA using PCR and sequencing techniques. Prior to BioNTech, Andreas worked at the University Hamburg as a lecturer and researcher working on RNA folding and ribosomal translation. He received his PhD in biochemistry from the University of Potsdam, where he investigated methods to assess quantity and activity of tRNAs.