Implementing the Colony-Forming Unit (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.

Click to watch the webinar recording. To view the presentation full screen simply click the square icon located in the bottom-right corner of the video-viewer.

Presenters

Colin Hammond, PhD

Scientist
Research & Development
STEMCELL Technologies

Dr. Colin Hammond works as a Scientist at STEMCELL Technologies, optimizing and developing assay workflows. He has spent 10 years investigating the functional and molecular heterogeneity of human hematopoietic stem and progenitor cells, focusing on the processes of aging, differentiation, and leukemic transformation.

Production Partner

STEMCELL Technologies Inc.

STEMCELL Technologies provides specialized cell culture media, cell isolation products, and reagents for your cell therapy and drug discovery research. Our ethically sourced human primary cell portfolio includes products from peripheral blood, cord blood, and bone marrow.

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