Automated production technologies for mRNA-based drugs

The image depicts a modern, compact computer system module with a cassette drive front panel. It has a futuristic look, featuring a white body with a light blue illuminated border all around and a smooth, minimalist surface. The front panel features several cassette doors. The focus is on the case.
© Fraunhofer IPA

Allogeneic cell therapies are revolutionizing medicine – but until now, their manufacturing has been complex, inflexible, and highly manual. The dynamic expansion system is the next-generation bioprocess module for automated manufacturing of allogeneic NK cell therapies, overcoming these limitations: robust, safe, efficient, and digitally controlled, it enables scalable, standardized production with minimal manual intervention. This ensures not only the highest quality but also significantly reduces costs and accelerates the scale-up of your therapies. Transform your production – where innovation begins – with the dynamic expansion system.

Key advantages

  • Reliable cell cultivation – Developed expansion module for maximum process security
  • Seamless automation – Cassette-based architecture for automated handling and effortless integration into robotic workflows
  • Full transparency – Integrated sensor suite and digital monitoring via digital twins for real-time insights into cultivation
  • Maximum safety – Closed, contamination-­free fluidic path
  • Intelligent control – Predictive, model-­driven process control for consistent results
  • Digitally connected – Pharma 4.0-ready control architecture for seamless integration into digital manufacturing environments

Dual-membrane culture technology

  • Flexible cultivation – Supports both sedimentation and suspension states of the cells
  • Gentle processes – Enables gentle resuspension and reduces shear stress
  • Resource-efficient – Minimizes media consumption while maximizing yield
  • Highest quality – Improved homo­geneity and vitality of the culture for better therapeutic outcomes
The image shows an isometric rendering of a modular expansion cassette unit, viewed from above. It features a long, curved base with an open, hollow structure that reveals internal components and slots. The front section includes a few rectangular panels and connectors, while the center contains a tall, cylindrical tower with additional gear-like elements and small green accents. The color palette is light gray with subtle blue-gray shading, set against a pale blue background.
© Fraunhofer IPA

Adaptive bioreactor chamber

  • Volume adjustment – Automatically adapts internal volume during cultivation based on cell density
  • No manual transfers – Eliminates handling steps for increased process safety
  • Stable microenvironment – Provides a consistent, scalable environment for cultivating sensitive cell types
  • Minimized effort – Reduces operator interventions to a minimum

Integrated plasma-based multi-sterile connector

  • Optimized workflow – Streamlines processes in automated bioprocess chains
  • Higher process security – Reduces manual handling and increases reproducibility
  • Closed system exchange – Enables cassette changes without contamination risk
  • Sterile sampling – Allows automated, repeated sampling without compromising sterility
The image shows a gray industrial connector assembly laid horizontally on a light surface. It consists of a central cylindrical housing with flanged ends and multiple smaller cylindrical components connected along its length. Both ends feature a blue-tinned circular cap.
© Fraunhofer IPA

Integrated sensors

  • Monitor pH, dO2, dCO2, glucose, and lactate in real time
  • Enable digital twin-based monitoring and predictive process adjustments

Predictive process control

  • Real-time monitoring – Integrated, model-based prediction of cell growth using real-time sensor data for continuous process control
  • Automatic optimization – Enables automated media supply based on fore­casted consumption for ongoing improvement of cultivation
  • Consistent quality – Ensures uniform product quality across all production batches

Pharma 4.0-ready architecture

  • Plug & Produce – Immediate integration into existing production environments without extensive retrofitting
  • Full traceability – Comprehensive support for traceability and auditability for regulatory compliance
  • Digital documentation – Automated digital batch records for paperless batch reporting