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.
Predictive In Vitro Models for Toxicity Testing and Liver Research
Having validated tools to perform predictive assays in a biologically-relevant system is key to success in drug discovery research. In this webinar, Dr. Terry Riss (Promega Corp) and Jennifer Christie (STEMCELL Technologies) discuss products and protocols that enable the incorporation of validated in vitro alternatives to animal models for toxicology studies. First, Dr. Riss presents in vitro assays for 3D cultures that monitor drug-induced cytotoxicity and explains how different assays can be multiplexed to measure multiple cell health parameters. Following this, Ms. Christie describes how to generate mature and functional hepatic organoids using HepatiCult™ and demonstrates their applications in liver research and hepatotoxicity assessment.