Development and validation of clinical flow cytometry assays for modalities including cell and gene therapies
The rapid progression of cell and gene-based therapies has presented specific challenges to the current models for bioanalysis, as traditionally applied to small molecule and protein therapies. Flow cytometry represents a versatile platform, which has many potential uses within all stages of drug development. In addition, flow cytometry acts as a tool to measure key matrices that can contribute to the clinical outcome, including the number of cells expressing the encoding protein as well as the level of expression of that protein. Measuring these pivotal aspects helps to understand the behaviors of cell-based therapies and can impact assessment and efficacy.
Cell and gene therapies are challenging our use of flow cytometry by demanding answers to more complex questions. For example, can flow cytometry be used for exposure measurement? Can sufficient robust data be generated and used as a basis for pharmacokinetic measurement and modeling? The key to these successful approaches is the rigorous development and validation of flow cytometry assays, which should be performed while considering the current recommendations for validation of assays performed by flow cytometry, as cited in the 2021 CLSI H62 guidelines.
Adding to this challenge is a move towards global clinical trials and the necessity to compare data from multiple analytical sites. In this webinar, we will discuss the flow cytometric capabilities Charles River can offer to support drug development from discovery through preclinical testing and into clinical analysis.
What will you learn?
- Important aspects of flow cytometry instrumentation
- Current recommendations related to the validation of flow cytometry assays
- Charles River’s capabilities for clinical flow cytometry support
- Case study to illustrate cross-site validation of clinical flow cytometry assays
Who may this interest?
- Flow cytometry practitioners
- Analytical and bioanalytical chemists/scientists
- Innovator pharma
- Mid-tier biotech and pharma
- Preclinical and clinical R&D scientists
- Translational scientists
- Clinical monitors
Speakers
Abigail Forrest
Associate Director of Immunology
Charles River (NV, USA)
Abigail Forrest is the Associate Director of Immunology at Charles River (NV, USA), and has been in a scientific role for over 10 years. She leads a group that performs flow cytometry methods (immunophenotyping, receptor occupancy), cell-based assays (NAbs, ELISpot) and biomarker (cytokines, complement, TDAR) assays to support preclinical safety assessment for a wide range of drug modalities. Her group has extensive experience in clinical program support utilizing flow cytometry assays for the PD/PK assessments of a range of therapeutic agents including cell-based therapies and ELISpot assays for the assessment of antigen specific T cell cytokines responses to a variety of gene therapies.
Byoung Koh
Senior Research Scientist
Charles River (NV, USA)
Byoung Koh is a Senior Research Scientist in the Immunology group within the Laboratory Sciences group at Charles River (NV, USA) and has been in this role for 4 years. His expertise is in the method development, validation and sample analysis for flow cytometry-based methodologies including immunophenotyping and receptor occupancy methods to support preclinical and clinical programs. Previously, Byoung served as the Assistant Director of the Fluorescence Activated Cell Sorting and Flow Cytometry Shared Resources Laboratory at the University of Nevada, School of Medicine (NV, USA) where he developed his expertise through his collaborations in various areas of basic research in physiology and cell biology. Through 15 years of research experience, Byoung identifies optimal assay designs and scientifically sound assay development/validation approaches in a field with limited regulatory guidance and industry standards to ensure the quality support of immunotherapy and cell therapy programs.
Fiona Campbell
Study Director
Charles River (Edinburgh, UK)
Fiona Campbell is a Study Director in the Immunology group at Charles River (Edinburgh, UK) and has been in this role for over 5 years. Fiona leads a group that performs flow cytometry assays including immunophenotyping and receptor occupancy, as well as ELISpot, Cytokine Release Assays, Haemolysis and TDAR assays to support preclinical and clinical safety assessments. Her expertise is in method development and validation, sample analysis and project management. Her group has experience in supporting clinical flow cytometry programs for the assessment of a range of therapeutics including cell-based therapies.
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