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.
MesenPure™: For Highly Enriched Mouse MSC Cultures
The MesenCult™ Proliferation Kit with MesenPure™ (Mouse) has been optimized for the enrichment and expansion of mouse bone marrow- and compact bone-derived mesenchymal stem cells (MSCs) as early as passage 0
Pluripotent Stem Cells
Few areas of biology currently garner more attention than the study of human pluripotent stem cells (hPSCs)