Spectral Flow Cytometry in the Clinical Arena

 A Robust Platform for Immune Monitoring and Biomarker Discovery in Clinical Trials

As the importance of cellular biomarkers in the drug development process grows, the value of deep immune profiling, achieved through high-parameter single-cell analysis, has the potential to dramatically increase our understanding of the immune landscape in the context of disease and treatment. When adopted into a clinical setting, the expanded knowledge from large parameter datasets, often generated from limited sample volumes, could alter our approach to drug discovery and efficacy.  Spectral Flow Cytometry (SFC) has shifted the long-standing paradigm of one fluorochrome / one detector measurement by capturing the full emission spectrum across each laser used in the system.  This advancement, coupled with the ongoing development of spectrally unique dyes, makes SFC particularly well suited to support the growing requirement for superior resolution, increased sensitivity, and more comprehensive immunophenotyping in the clinical arena.  Given both the complexity of high-parameter flow cytometry assays and the global nature of clinical trials, minimization of variability through instrument and assay harmonization and standardization is essential for data reproducibility.  Successful platform adoption relies on defining and limiting variability to support the intended context of use.  As such, condition-specific instrument performance qualification through the generation of Cross Stain Index (CSI) (and/or Spillover Spread Matrix (SSM)) represents a powerful tool to confirm intra- and inter-instrument harmonization across a global fleet.  Following standardization to a single set of target MFI values, high-parameter assays optimized and validated as fit-for-purpose can be transferred to multiple instruments, across a global flow cytometry delivery network. The successful implementation of these steps results in the generation of consistent population frequency and fluorescent intensity outputs from high-parameter assays. The Cytek^® Aurora spectral flow cytometer has demonstrated the ability to be a robust platform for immune monitoring and biomarker discovery in clinical trials.

Key topics discussed in the webinar will include:

• Application of spectral flow cytometry in clinical trials; opportunities, risks, and recommendations
• Pathway to successful platform adoption including instrument harmonization, instrument standardization, and assay validation
• Assay performance at standardized settings

Who should attend? 

• Flow cytometry users looking to minimize variation and ensure data reproducibility, especially across multiple instruments and/or multiple sites
• Scientists using flow cytometry for immune monitoring and biomarker discovery in clinical trials
• Anyone interested in flow cytometry fundamentals

For Research Use Only. Not intended for use in diagnostic procedures.