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LIST OF CONTRIBUTORS xi PART I FROM COUNTING CELLS TO DECODING IMMUNITY 1 1 The History of Flow Cytometry 3 2 History and Future of Immune Monitoring by Flow Cytometry: From Counting CD4 T Cells to High-Parameter Spectral Cytometry 29 3 Advancement in Immuno-Oncology Biomarkers and Drug Development 49 PART II FLOW CYTOMETRY ACROSS THE DRUG DEVELOPMENT LIFECYCLE 77 4 High-Throughput Screening and CRISPR Editing: Utilizing Cell Sorting for Target Identification in Drug Discovery 81 5 Automated Flow Cytometry in Commercial Toxicology: Asedasciences' SYSTEMETRIC Cell Health Screen 109 6 The Impact of Pre-Analytical Sample Handling on Translational Biomarkers 137 7 Flow Cytometry Enabling Cellular Biomarkers 153 8 Monitoring of Residual Leukemia and Lymphoma in Clinical Trials 167 9 Monitoring of Cell Therapy Products in Clinical Trials 185 10 The Applications of Flow Cytometry and Receptor Occupancy Assays in the Development of Immunotherapeutic Compounds 205 11 Flow Cytometric Characterization of Single-Cell Functional Immune Responses Using the Intracellular Cytokine Staining Assay 215 12 Immunogenicity Testing Using the Flow Cytometry Platform 237 13 Extracellular Vesicles in Drug Discovery and Development 253 14 Flow Cytometry Applications in GMP Compliant Cell Therapy Manufacturing Process Development, Starting Material and Product Release, Stability, and Product Lifecycle Management 287 PART III REGULATION, STANDARDS, AND THE MEASUREMENT FOUNDATIONS OF FLOW CYTOMETRY 317 15 Flow Cytometry in Diagnostics and Drug Discovery: Impact of Global IVD Regulatory and Validation/Traceability Guidelines 319 16 NIST Flow Cytometry Standards Consortium 343 PART IV TRANSFORMING CYTOMETRY FOR THE FUTURE 359 17 Artificial Intelligence in Clinical Flow Cytometry 361 18 Molecular Cytometry for Translational Immune Profiling 377 INDEX 385 |
VIRGINIA M. LITWIN, PhD, is a thought-leader in validation and standardization for flow cytometry. She is President of the International Society for the Advancement of Cytometry and in 2023 received the International Clinical Cytometry Society Coulter award in recognition of her contributions to the science, education and practice of Clinical Cytometry. She chaired Clinical and Laboratory Standards Institute Committees for H62 and H42.
PRATIP K. CHATTOPADHYAY, PhD, is internationally recognized for his work developing and applying single-cell technologies, having played central roles in the introduction of various dyes, instrument platforms, and informatic approaches commonly used today. His career spans government (NIH), academics (Founding Director, NYU Precision Immunology Laboratory), and entrepreneurship (CEO, Founder, Talon Biomarkers).