Despite the various designs and distinctive tumor-specific scFvs, the manufacturing procedure for CAR-T cells remains consistent. The procedure encompasses T-cell source collection and processing followed by CAR-T cell preparation; the latter involves T-cell selection and/or activation, genetic modification with a CAR cDNA followed by large-scale expansion, and end-of-process formulation. In-process and quality control release testing are intimately coupled to the manufacturing process to ensure the integrity of the product. The removal of open handling, along with implementing closed culture systems, provides a reliable solution.

The iLine F analyzer with its patented technology, double differential digital holographic microscopy (D3HM), offers a quantitative imaging solution that allows T-cell monitoring in a large-scale expansion in a continuous, dye-free setup. Cell expansion takes place in bioreactors with closed tubing and connections, maintaining a sterile environment. There is no need for sampling (eliminating the risk of contamination) or waiting for results to be generated by an off-line counter or analyzer: results are available in almost real time and cover the duration of the culturing process.

Continuous in-process controls are possible via OPC (Open Platform Communications) and have been extensively cross-validated against multiple cell counting methods.

Our customers have reported that our iLine F analyzer:

• Accelerates process development and characterization.
• Improves process & product understanding through real-time attribute monitoring.
• Reduces process & product variability through feedback process control.
• Promotes closed cell therapy processing.
• Reduces COGs.