2 results match your criteria: "Eurofins Clinical Trial Solutions[Affiliation]"
Using Spectral Flow Cytometry for CAR T-Cell Clinical Trials: Game Changing Technologies Enabling Novel Therapies.
Int J Mol Sci
September 2024
Eurofins Clinical Trial Solutions, Montreal, QC J2L 3N5, Canada.
Article Synopsis
- Monitoring CAR T-cells in clinical trials requires specialized flow cytometry to assess not just individual patient outcomes but also the overall effectiveness of therapies.
- Data collected from multiple labs will be compiled into a single database for broader analysis, including modeling cellular behavior and identifying potential predictive biomarkers.
- To ensure valuable and reliable results, there are strict standards for assay validation, calibration, technology transfer, standardization across instruments, and compliance with regulations.
Flow cytometry assay modifications: Recommendations for method validation based on CLSI H62 guidelines.
Cytometry B Clin Cytom
August 2024
Division of Hematopathology, Department of Pathology and Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.
The Clinical and Laboratory Standards Institute (CLSI) H62-Validation of Assays Performed by Flow Cytometry guideline, released in 2021, provides recommendations for platform workflow and quality system essentials, instrument setup and standardization, assay development and optimization and fit-for-purpose analytical method validation. In addition, CLSI H62 includes some recommendations for the validation strategies after a validated flow cytometric method has been modified. This manuscript builds on those recommendations and discusses the impact of different types of assay modifications on assay performance.
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