Fraunhofer Institute for Production Technology IPT
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Research project "RNAuto"
In recent years, mRNA-based vaccines as well as gene and cell therapeutics have permanently changed the medical landscape. These novel therapeutics offer promising approaches for the prevention and treatment of infectious diseases, hereditary diseases and cancer. During the COVID-19 pandemic in particular, mRNA vaccines have caused a global sensation and shown how quickly and effectively this technology can be used to develop life-saving vaccines.
The potential of mRNA-based therapies is huge. However, their production poses a challenge. The development of new manufacturing processes has still not kept pace with the rapid biomedical progress in these areas. Current manufacturing processes are often manual and subject to stringent good manufacturing practice (GMP) requirements. Despite the challenges, the demand for Advanced Therapy Medicinal Products (ATMPs) and novel therapies is high. This is why fully digitalized, automated production processes (Pharma 4.0) are needed in order to be able to offer tailored, personalized therapies to as many patients as possible.
Seven Fraunhofer Institutes are therefore pooling their expertise in the fields of medicine, biology, production technology and engineering in the flagship project "RNAuto". The aim is to be able to produce mRNA vaccines along with gene and cell therapeutics automatically, quickly and cost-effectively in large quantities. One focus of the research work is the development of a screening system with digital process control and data-driven inline quality control, which can be used to encapsulate mRNA in lipid nanotransporters.
A major challenge in the development process of mRNA-based therapies is resource-efficient process development, particularly for the formulation and encapsulation of mRNA. Currently, a multitude of possible materials, production technologies and a lack of automation and digitalization lead to high time and costs in the laboratory. To address these challenges, the Fraunhofer IPT is co-developing a screening system for the automated encapsulation of mRNA. This system aims to identify the best material combinations and process parameters in the shortest possible time. By integrating online analytics, quality parameters can be recorded and the results reliably documented. This enables efficient and effective process development for mRNA-based therapies, further advancing the production of these life-saving drugs.
Objectives of the project
- Automated process for the packaging of mRNA in nanotransporters
- Development of a screening system for automated mRNA encapsulation with integrated online analytics for quality assurance and documentation for accelerated bioprocess development
- Expansion module with integrated quality control for the production of allogeneic gene and cell therapeutics
- mRNA-active ingredient candidates: Vaccine against West Nile virus, gene and cell therapeutics against hematologic cancers
Contributions of Fraunhofer IPT
- Adaptive control software "COPE"
- Expertise in the production of cell and gene therapeutics: Plant planning and development of the automation concept
- Development and validation of the screening platform
- Design and integration of analytics and sensor technology for quality assurance of the mRNA encapsulation process
Project partners
- Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
- Fraunhofer-Institut für Mikrotechnik und Mikrosysteme IMM
- Fraunhofer-Institut für Produktionstechnik und Automatisierung IPA
- Fraunhofer-Institut für Produktionstechnologie IPT
- Fraunhofer-Institut für Experimentelles Software Engineering IESE
- Fraunhofer-Institut für Mikroelektronische Schaltungen und Systeme IMS
- Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Funding information
The "RNAuto" research project is being funded by the Fraunhofer-Gesellschaft to the tune of 8 million euros.