Automated Platform Accelerates mRNA Drug Manufacturing

Messenger RNA (mRNA)-based therapeutics and vaccines have emerged as important tools in the treatment and prevention of infectious diseases, cancer and genetic disorders. However, the manufacturing of these products remains complex, requiring multiple manual interventions, intermediate quality checks and lengthy development cycles.

As demand for mRNA-based therapies continues to grow, pharmaceutical developers and manufacturers face challenges related to production scalability, process consistency and cost efficiency. Conventional manufacturing methods often struggle to deliver larger production volumes while maintaining stringent quality standards.

Development Goals for Automated Bioprocessing
Within the RNAuto research project, seven Fraunhofer institutes collaborated to develop a manufacturing platform capable of increasing production speed, improving process reliability and enabling scalable manufacturing of mRNA-based therapeutics.

The project aimed to reduce manual intervention, integrate quality monitoring directly into production and create a flexible system capable of supporting different drug variants and bioprocesses.

Automated Production with Integrated Quality Control
The resulting RNAuto platform combines automated manufacturing, digital process control and continuous quality monitoring within a modular production system.

During production, mRNA molecules are continuously formulated with lipids using a micromixer to create lipid nanoparticles. These nanoparticles act as protective carriers for the sensitive mRNA active ingredients, enabling delivery into target cells. Following formulation, the particles are stabilized, neutralized and filtered in a continuous manufacturing process.

A key feature of the system is the integration of quality control directly into production. Dynamic light scattering (DLS) technology continuously measures nanoparticle size and distribution, eliminating the need to stop production for manual sampling and laboratory analysis.

Digital Twins Support Process Optimization
Each production module is linked to a digital twin containing its technical specifications and operational data. Integrated sensors collect process information throughout manufacturing, creating structured digital documentation for every production run.

According to Fraunhofer researchers, this approach enables data-driven optimization of future production cycles while improving traceability and process transparency.

The modular architecture, developed with scalability in mind, allows manufacturers to adapt the platform to new bioprocesses and different active ingredient variants without redesigning the entire production line.

Supporting GMP-Compliant Manufacturing
Fraunhofer incorporated Good Manufacturing Practice (GMP) requirements throughout the development process. By considering regulatory requirements from the outset, the researchers sought to ensure that production quality and safety standards can be maintained as manufacturing volumes increase.

The system prototype was built at the Fraunhofer Institute for Production Technology IPT, while several participating institutes contributed expertise in molecular biology, software engineering, process development and microengineering.

Benefits for Drug Developers
The RNAuto platform enables pharmaceutical developers and manufacturers to produce mRNA-based therapeutics significantly faster than conventional approaches while increasing production volumes through continuous processing. The integration of automated quality control reduces process interruptions and minimizes manual intervention.

In addition, the modular design provides flexibility for developing new gene therapies, cell therapies and modified vaccines, allowing manufacturers to conduct testing and development programs more efficiently.

By combining automation, digitalization and integrated quality assurance, the RNAuto project demonstrates a practical approach to improving the availability of mRNA-based drugs and supporting the industrialization of next-generation therapeutics.

Edited by Sucithra Mani, Induportals editor – adapted by AI.

www.fraunhofer.com