Project RNAuto

There is huge potential for new mRNA-based pharmaceutical active compounds – following the Comirnaty and Spikevax vaccines, a large number of drug candidates for a wide range of applications have moved into the focus of attention. But the Corona pandemic has also shown that GMP-compliant mRNA manufacturing on an industrial scale is still in an early phase and a limiting factor. The Fraunhofer lighthouse project RNAuto unites the expertise of seven institutes in medicine, biology and engineering around the common goal of automating the manufacturing processes for mRNA drugs. The Fraunhofer approach covers the entire process chain from target sequence design to biological functionality testing of the manufactured nanopackaged mRNA. 

Fraunhofer ITEM´s role is in process development at laboratory scale as well as in scale-up and implementation in pharmaceutical quality standards. The information and knowledge thus gained will serve experts to develop scalable and robust platform processes. The aim is to cover complete manufacturing process sequences – starting from the DNA template, via linearization, transcription to RNA and subsequent purification, to packaging in stable lipid nanoparticles. Guided by the release analytics of already approved mRNA drugs, a suitable method spectrum for quality control of mRNA lipid nanoparticles will be developed in parallel.