RNAuto - Automated production technologies mRNA-derived vaccines, gene and cell therapeutics

In an affordable future healthcare system, innovative drugs, such as new types of vaccines or gene and cell therapeutics based on mRNA, will be made available to a large number of patients. This calls for automated production technologies for manufacturing such products safely and reliably in accordance with stringent pharmaceutical requirements (GMP certification). To develop an AI-controlled, digitally controlled and automated production process with Industry 4.0 in mind, the consortium is pooling interdisciplinary expertise from medicine, biology and engineering.

The project partners are focusing on two drug candidates to demonstrate process automation. One is a prophylactic mRNA vaccine against the viral disease West Nile fever; the other is mRNA-induced gene therapeutics against cancer based on natural killer cells (NK cells) from healthy donors.

The consortium is working on an automated screening facility to speed up the development of mRNA nanotransporters with a digital image for process control and quality control, as well as an expansion module with integrated quality control for manufacturing allogenic gene and cell therapeutics. Key biological challenges lie in the fundamentally limited stability of mRNA molecules and in correctly encapsulating the mRNA in lipid nanotransporters. A particular research focus is on automating the technologies up to industrial scale and on scaling up the production of mRNAs, mRNA nanotransporters, and mRNA-modified cells.