Applications

Cell Therapy’s Platform for Automated QC Analytics

Stringent process controls are needed to measure critical parameters of the cell product at every step, from patient sample acquisition to drug product release.

Over the past three years the Accellix platform has been embraced by leading immunotherapy companies as it enables streamlining in-process quality control analytics during manufacturing and final analytical QC for release of cell products.

Accellix Assay Migration Overview

  • PHASE
    1

    Development

    • Discuss assay and software requirements
    • Design fluorophore panel
    • Acquire reagents and titrate dyes/conjugates
    • Verify performance pre/post drying with sample provided by customer
  • PHASE
    2

    Optimization

    • Evaluation at customer site under use-case conditions
    • Auto-analysis development
    • Customization of user interface
    • Customer feedback and optimization of assay, software
  • PHASE
    3

    Tech Transfer & Release

    • Establish assay kit QC criteria
    • Generate documentation
    • Train manufacturing team
    • Release to customer for assay validation