In the lighthouse project “RNAuto”, seven Fraunhofer Institutes are collaborating to develop automated production technologies for mRNA-based medicinal products. The consortium bundles interdisciplinary competencies from the fields of medicine, biology, and engineering sciences.
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The development of drugs such as gene and cell therapeutics and mRNA vaccines is booming. Driven not least by the COVID-19 pandemic, the market for advanced therapy medicinal products (ATMPs) is growing steadily. These advanced therapy medicinal products are a groundbreaking milestone in the treatment of complex, hitherto incurable diseases. For some types of cancers, they are often the last option for successful treatment of the patient. However, ATMPs are still only administered rarely. One limiting factor is the extremely labor-intensive and, to date, often manually performed manufacturing process. Quality assurance, too, is time-consuming and cost-intensive.
In order to be able to offer targeted, personalized therapies to as many patients as possible, digitalized, automated production processes (Pharma 4.0) are required. In the lighthouse project RNAuto, seven Fraunhofer Institutes are therefore bundling their competencies in the fields of medicine, biology, production engineering, and engineering sciences. The aim is to be able to produce mRNA vaccines as well as gene and cell therapeutics in an automated manner, quickly and cost-effectively, in large quantities. One focus of the research is the development of a screening facility with digital process control and data-driven inline quality assurance that can be used to encapsulate mRNA in nanotransporters made of lipids. The project team is initially aiming for mRNA active ingredient production on a laboratory scale of up to 20 ml, with the concept being scalable up to industrial scale.
Fraunhofer Institute for Experimental Software Engineering IESE