Fraunhofer Institute for Cell Therapy and Immunology IZI
Fraunhofer Institute for Cell Therapy and Immunology IZI

Automated production technologies for mRNA-based drugs

In-line cell quality control for gene and cell therapy fabrication processes

Pharmaceutical factory worker operating production line at pharmacy industry, man use clipboard for control quality.
© parilov - stock.adobe.com

For a reliable and continuous control of cell quality in pharmaceutical manufacturing processes, we provide technologies and expertise to develop a miniaturized in-line flow cytometer for easy integration into flow-through facilities. Based on single-photon detection technology, it enables the detection even of the weakest fluorescent samples and provides an exceptional temporal and optional spectral resolution.

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Advantages

  • Early detection of undesired cells and contamination before and after cell expansion with in-line flow cytometry
  • Safe time and effort in cell and gene fabrication processes
  • Continuous – No interruptions of the fabrication process needed
  • Reliable – Real-time analysis for rapid contamination response
  • Resource efficient – Minimal material waste and reflow option
  • Scalable – High-throughput detection of cells in flow
  • Customizable – Tailor the measurement parameters to your needs
Schematic overview of cell quality control process
© Fraunhofer IMS

Technical specifications

  • Detectors: Single-photon avalanche diodes (SPAD)
  • Time resolution: < 1 ns
  • Time bins for counting: 5–20 ns
  • Wavelengths: Single and spectrum
  • Dark-count rate: < 0.1 counts/μm²s
  • Lasers: Application-dependent
SPAD-Chip for time-resolved fluorescence measurements
© Fraunhofer IMS
In-house developed and fabricated SPAD-Chip for time-resolved fluorescence measurements.

Performance

  • Event rate: Up to 2.000 events/s (e.g. cells/s)
  • Fluorescence sensitivity: < 100 MESF (Molecules of Equivalent Soluble Fluorochrome)
  • Fluorescence lifetime, Resolution: 1.3–5 ns
  • Fluorescence spectrum: 400–900 nm (selectable)
  • Forward-Scattering (FSC): Application-dependent
  • Sideward-Scattering (SSC): Application-dependent

Applications

  • Cell counting (sorting on demand)
  • Cell viability detection (stained)
  • Biomarker detection (stained)
  • Label-free cell detection (autofluorescence)
  • …
In-line cell quality control module based on flow cytometry
© Fraunhofer IMS
In-line cell quality control module based on flow cytometry.