Clinical Flow Cytometry: Validation and Implementation in a Regulatory Setting

Presented by Chelsea Riveley, BA Biology, MBA
Director of Business Development and Greg Bannish, PhD Head of Flow Cytometry Services

This webinar provides an overview of flow cytometry and its potential uses in the clinical setting. A case study will be presented to detail the unique aspects of conducting clinical flow cytometry in a regulated setting. The following phases of developing and validating a robust and reliable flow cytometry assay will be illustrated in the case study:

  • The first critical step to any flow cytometry assay – panel design
  • Descriptions of validation test scripts that should be conducted along with suitable acceptance criteria
  • Proper instrument set-up and appropriate controls
  • Gating strategy and identification of cell subsets
  • Correct interpretation of flow cytometry data

Lastly, what to look for when choosing an outsourcing partner for flow cytometry will be discussed. These include some of the key decision points and factors to consider such as expertise, regulatory requirements, logistics, timelines, and price.