Implementing the Colony-Forming Unit (CFU) Assay As a Potency Assay for Hematopoietic Cell Therapy Products
Assessing the functional potency of cells for use in cell therapy research presents unique challenges. For hematopoietic stem and progenitor cells (HSPCs) in particular, potency can be measured in vitro by assessing the ability of these cells to differentiate into progenitor cells using the colony-forming unit (CFU) assay. Validating the CFU assay as a potency assay requires demonstrating its specificity, accuracy, precision, linearity, and reproducibility. Once validated, the CFU assay can assess the quality and consistency of prospective hematopoietic cell therapy products (HCTPs) at multiple stages of the processing and manufacturing workflow.
Join Dr. Colin Hammond and learn about the regulatory guidance around the potency testing of HCTPs and how to validate the CFU assay as a potency assay that can be integrated into cell therapy manufacturing workflows.
Tools for Optimizing Human Immune Cell Research
Obtaining consistent and reliable results when culturing immune cells can be challenging. Watch this webinar to discover how to obtain high yields of functional T cells, NK cells, B cells, dendritic cells, and macrophages for your research applications. The speaker, Evan Karas, also explains how to expand primary T cells without feeders or serum.
How to Use Primary Cells to Develop the Next Therapy
Human primary cells are cells isolated directly from tissues, including blood and bone marrow. The use of human primary cells increases the physiological relevance of cell culture systems, enabling you to generate meaningful data that is more predictive of in vivo outcomes. Learn about the advantages of starting with human primary cells for your immunology and cell therapy research workflows. Key considerations for choosing the ideal starting material, donor characterization, regulatory challenges, and tips to streamline your cell-based assays with human primary and cultured cells are also covered.
Daniel Gray, PhD
Dr. Daniel Gray describes his work studying cell death and the potential applications in drug development for immune disorders
David Knapp, PhD
Dr. David Knapp shares his work examining how growth factors affect the survival, proliferation, and maintenance of cells of the cord blood HSC compartment
Courteney Lai
Courteney Lai describes her work in the Humphries' lab studying leukemic stem cell function using models of acute myeloid leukemia
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Implementing the Colony-Forming Unit (CFU) Assay As a Potency Assay for Hematopoietic Cell Therapy Products Assessing the functional potency of cells for use in cell therapy research presents unique challenges. For hematopoietic stem and progenitor cells (HSPCs) in particular, potency can be measured in vitro by assessing the ability of these cells to differentiate into progenitor cells using the colony-forming unit (CFU) assay. Validating the CFU assay as a potency assay requires demonstrating its specificity, accuracy, precision, linearity, and reproducibility. Once validated, the CFU assay can assess the quality and consistency of prospective hematopoietic cell therapy products (HCTPs) at multiple stages of the processing and manufacturing workflow.
Tools for Optimizing Human Immune Cell Research Obtaining consistent and reliable results when culturing immune cells can be challenging. Watch this webinar to discover how to obtain high yields of functional T cells, NK cells, B cells, dendritic cells, and macrophages for your research applications. The speaker, Evan Karas, also explains how to expand primary T cells without feeders or serum.
How to Use Primary Cells to Develop the Next Therapy Human primary cells are cells isolated directly from tissues, including blood and bone marrow. The use of human primary cells increases the physiological relevance of cell culture systems, enabling you to generate meaningful data that is more predictive of in vivo outcomes. Learn about the advantages of starting with human primary cells for your immunology and cell therapy research workflows. Key considerations for choosing the ideal starting material, donor characterization, regulatory challenges, and tips to streamline your cell-based assays with human primary and cultured cells are also covered.
Daniel Gray, PhD Dr. Daniel Gray describes his work studying cell death and the potential applications in drug development for immune disorders
David Knapp, PhD Dr. David Knapp shares his work examining how growth factors affect the survival, proliferation, and maintenance of cells of the cord blood HSC compartment
Courteney Lai Courteney Lai describes her work in the Humphries' lab studying leukemic stem cell function using models of acute myeloid leukemia
