Quality-by-Design is usually understood as a systematic approach to pharmaceutical development that starts with predefined objectives and quality risk management, and focuses on product/process understanding and scientifically sound process control. What happens when we transfer this approach from product/process understanding to a biological/biochemical assay for the detection of any analyte or otherwise, understanding the individual steps of the wet lab assay/method as a process? In this presentation, we show how we optimized a flow cytometric method for the detection of CAR-T cells in fresh peripheral blood from pre-processing sample to measurement using Quality-by-Design and Design-of-Experiments and investigated the robustness of the assay. This approach allowed us to develop a solid understanding of the method in terms of the optimum and the edge of failure for each laboratory parameter investigated, so that the method could be used for immune monitoring projects in clinical trials after subsequent validation and reagent qualification.
Learning Objectives:
decide whether Quality-by-Design/Design-of-Experiment based method optimization is a benefit to the laboratory/method.
understand how Quality-by-Design/Design-of-Experiment can save wet-lab time and support the knowledge gain with respect to a method.
get a sense of how to develop a robust analysis method statistically-based that enables more reliable measurement/characterization of your product