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.
Applications of Human Intestinal Organoid Cultures in Drug Discovery
Human intestinal organoids provide a scalable and highly predictive model system for studying the effects of novel therapeutics in vitro. Intestinal organoids contain the relevant cell types that constitute the intestinal epithelium and, as such, can be maintained in various states of proliferation or differentiation. These physiologically relevant models reveal the toxicity of compounds that can not be seen in Caco-2 cells, which are frequently used to model the intestine during drug development programs.
In this webinar, Danny Leung and Dr. Victoria Conlin from STEMCELL Technologies describe, in detail, what intestinal organoids are, how they mimic the immunocytochemistry and morphology of the human gut epithelium, and how to use organoids for drug screening. They also discuss the intestinal organoid assays offered by Contract Assay Services (CAS) at STEMCELL Technologies.
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.