Flow Cytometry in Drug Discovery and Development

2 ed
ISBN: 978-1-394-24026-5
Verlag: John Wiley & Sons Inc

Buch, Englisch, 416 Seiten

Apply flow cytometry to drug discovery and development

The growth of immunotherapy and cellular therapies has dramatically expanded flow cytometry’s role in drug development, while, in parallel, advances in single-cell analysis have transformed the field. Now in its Second Edition, Flow Cytometry in Drug Discovery and Development focuses on pharmaceutical applications, helping translational scientists apply flow cytometry and helping cytometrists understand the pharmaceutical applications.

Where other references concentrate on general laboratory protocols or instrument specifications, this book targets the intersection of single-cell analysis and drug development. It equips readers to evaluate drug and therapy quality using high-content analytical techniques including multiparametric analysis of single cells.

Readers will also find:

- Guidance on applying simultaneous multiparametric single-cell analysis to pharmaceutical quality assessment and therapeutic development programs
- Updated content reflecting the dramatic expansion of immunotherapy and cellular therapy applications since the first edition
- Practical frameworks connecting flow cytometry techniques to specific stages within the drug discovery and development pipeline
- Coverage of related technologies advancing single-cell analysis beyond conventional flow cytometry for drug development contexts
- Perspectives relevant to professionals across academia, contract research organizations, biotech, and pharmaceutical industry settings

Designed for pharmaceutical and biotech scientists, analytical chemists, clinical investigators, bioengineers, and university researchers, this Second Edition serves professionals working at the intersection of single-cell analysis and drug development. Instrument vendors supporting drug development workflows will also find it a targeted resource.

Autoren/Hrsg.

Litwin, Virginia M.

Chattopadhyay, Pratip K.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie

Inhaltsverzeichnis

LIST OF CONTRIBUTORS xi
PREFACE xv
ACKNOWLEDGMENTS xxi

PART I FROM COUNTING CELLS TO DECODING IMMUNITY 1

1 The History of Flow Cytometry 3
Bieke Soen, Nithianandan Selliah, Anissa Fries, and Christèle Gonneau

2 History and Future of Immune Monitoring by Flow Cytometry: From Counting CD4 T Cells to High-Parameter Spectral Cytometry 29
Florian Mair

3 Advancement in Immuno-Oncology Biomarkers and Drug Development 49
Yi-Dong Lin, Mark Elliott, and Jiangfang Wang

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
Alberto Moreno de la Gandara, Larissa Catharina Costa, Mark Cheetham, Derek Davies, Asif Nakhuda, Sam Thompson, and Rachael V. Walker

5 Automated Flow Cytometry in Commercial Toxicology: Asedasciences' SYSTEMETRIC Cell Health Screen 109
Andrew A. Bieberich

6 The Impact of Pre-Analytical Sample Handling on Translational Biomarkers 137
Matthew Kunicki, Melvin Lye, and Christoph Eberle

7 Flow Cytometry Enabling Cellular Biomarkers 153
Thomas Beadnell, Susmita Jasti, and Virginia M. Litwin

8 Monitoring of Residual Leukemia and Lymphoma in Clinical Trials 167
Brent L. Wood

9 Monitoring of Cell Therapy Products in Clinical Trials 185
Mahwish Natalia

10 The Applications of Flow Cytometry and Receptor Occupancy Assays in the Development of Immunotherapeutic Compounds 205
James White, Thomas Beadnell, and Virginia M. Litwin

11 Flow Cytometric Characterization of Single-Cell Functional Immune Responses Using the Intracellular Cytokine Staining Assay 215
Katharine V. Schwedhelm and Stephen C. De Rosa

12 Immunogenicity Testing Using the Flow Cytometry Platform 237
Ruqi Wang, Virginia M. Litwin, and James White

13 Extracellular Vesicles in Drug Discovery and Development 253
John P. Nolan and Samuel T. Orozco

14 Flow Cytometry Applications in GMP Compliant Cell Therapy Manufacturing Process Development, Starting Material and Product Release, Stability, and Product Lifecycle Management 287
Shibani Mitra-Kaushik and Mahwish Natalia

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
Gerald E. Marti and Bruce H. Davis

16 NIST Flow Cytometry Standards Consortium 343
Paul C. DeRose, John T. Elliott, Edward J. Kwee, Jamie Almeida, Sheng Lin-Gibson, and Lili Wang

PART IV TRANSFORMING CYTOMETRY FOR THE FUTURE 359

17 Artificial Intelligence in Clinical Flow Cytometry 361
Ryan C. Shean and David P. Ng

18 Molecular Cytometry for Translational Immune Profiling 377
Pratip K. Chattopadhyay

INDEX 385

Über Autor(innen)

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).