Implementing the CFU Assay As a Potency Assay for Hematopoietic Cell Therapy Products

Join our webinar to learn how to effectively implement the CFU assay as a potency assay for hematopoietic cell therapy products.

FDA recommendations require quantitative assays to demonstrate the functional potency of cell therapy products. For hematopoietic cell therapy products (HCTP), hematopoietic stem and progenitor cell (HSPC) potency can be measured by assessing the number of colony-forming units (CFU) using the CFU assay. Furthermore, in patients receiving unrelated allogeneic cord blood transplants, functional potency, measured by the total number of CFUs, has been shown to best correlate, among other parameters, with overall survival and the time to neutrophil and platelet engraftment.

Validating the CFU assay as a potency assay requires demonstrating its specificity, accuracy, precision, linearity, and reproducibility. Once validated, the CFU assay can be used to assess product quality and consistency at multiple stages of the HCTP processing and manufacturing workflow.

In this webinar, Dr. Colin Hammond from STEMCELL Technologies will discuss some of the regulatory guidance around HCTP, as well as how to validate the CFU assay as a potency assay that can be integrated into cell therapy manufacturing workflows.

Key Topics Include:
Learn about the CFU assay and its characteristics as a biological tool in assessing hematopoietic stem and progenitor cells.
Discover the utility of using bioassays to assess product potency in hematopoietic cell therapy workflows.
Review methods to validate the CFU assay as an in-house potency assay.
Explore ways to standardize and improve CFU assay throughput.

To learn more, go to: https://insidescientific.com/webinar/...