Seven Fraunhofer institutes are working on the development of automated production technologies for mRNA-based drugs. RNAuto is a Fraunhofer lighthouse project that will receive €8 million in funding from the Fraunhofer-Gesellschaft over the next four years.
mRNA-based vaccines, along with gene and cell therapeutics, represent innovative drugs that can be used to prevent and/or treat infectious diseases, genetic disorders and cancer. Development of these innovative drugs has been prodigious in recent years in terms of clinical research, translation and application. But advancement of the required production technologies has not yet managed to keep pace with the rapid biomedical progress made in these areas. Hence the need for automated and digitally supported production technologies that facilitate not only the rapid, safe and reliable development of innovative mRNA drugs, but also their production in accordance with the high demands of good manufacturing practice (GMP).
This lighthouse project focuses on developing bioprocessing methods and production technologies for the modular and automated manufacture of mRNAs, mRNA nanocarriers and mRNA-modified cells that can be scaled right up to industry level. For the automated manufacture of mRNA-based drugs to be successful, technical solutions will be established in the areas of bioreactors, fluid dynamics, quality control and automated data analysis. Core elements of the Industry 4.0 concept are to be deployed in order to digitally map and monitor the production processes.
The primary objective is to develop automated manufacturing processes for mRNA molecules that will smooth the way for sustainable and cost-efficient health care. In order to achieve its goal, the project brings together the expertise of various Fraunhofer institutes from the fields of vaccine development, cell and gene therapy, bioprocess development, smart sensor technology, and the automation and digitalization of production processes.
Fraunhofer ITEM will contribute its expertise in the development of RNA-based therapeutics and in bioprocess development and GMP production of biomolecules as investigational medicinal products to the RNAuto lighthouse project. The aim is to establish a scalable and robust technology platform for the development and manufacturing of mRNA-based drugs.
Through its lighthouse projects, Fraunhofer addresses current challenges facing German industry and sets strategic focus areas that will aid the development of specific solutions across Germany. The RNAuto lighthouse project will be financed by the Fraunhofer-Gesellschaft until the end of 2025 with €8 million in funding.
Fraunhofer Institute for Toxicology and Experimental Medicine