There are a vast number of cell therapy product candidates in clinical development today for various incurable diseases. In the coming years, the cell therapy landscape will evolve and grow substantially, leading to the introduction of new products in the market. Cell therapy includes engineering T-cells by extracting them from white blood cells, genetically modifying them into target cells, and multiplying them in a bioreactor before re-injection into patients.
A major challenge to commercializing cell-based therapies is developing scalable manufacturing processes while maintaining critical quality parameters (identity/ cell characterization, potency, purity, safety) of the final live cell product. Quality control testing accounts for about 25% of the manufacturing cost.
Cell characterization tools and technologies are critical to the successful development and scaling of therapeutic cell manufacturing processes. Currently, characterization assays are carried out by flow cytometry, which make up about 25%-30% of all testing done in broad cell therapy manufacturing.
Time and labor are the major cost contributors which the Accellix platform can reduce dramatically. For autologous T-cell therapies to become a mainstream treatment, the manufacturing process – including cell characterization – has to be simplified.
The first dedicated Accellix cartridge for T-cells includes an assay detecting CD45, CD3, CD4 and CD8 subpopulations of a sample, complete with a viability check by automated staining and data analysis of the sample, using the Accellix reader.
• Sample in, results out >> Make decisions faster, with results in 30 minutes
• Anyone can do it >> Fully automated process
• Trust the result >> Algorithm-based, standardized readout
• Single-use cartridge >> Disposable and accurate
We are working with leading players in the cell therapy industry to expand our product pipeline to include additional generic and proprietary testing cartridges.