Implementing the Colony-Forming Unit (CFU) Assay As a Potency Assay for Hematopoietic Cell Therapy Products

Webinar Summary

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.

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.

Presenters

Colin Hammond

STEMCELL Technologies (Research & Development)

Scientist

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.

STEMCELL Technologies Inc.

STEMCELL Technologies develops specialty cell culture media, cell isolation products and accessory reagents for life science research. Generate hPSC-derived cerebral organoids for a physiologically relevant in vitro model system with the STEMdiff Cerebral Organoid Kit. Use BrainPhys Neuronal Medium to culture active hPSC- and primary tissue-derived neurons in a physiological environment. The NeuroCult product line for primary and CNS-derived neural stem cells includes 30+ media and supplements, culture assays and differentiation kits. For human neurological disease modeling, the STEMdiff Neural System supports every step in your iPS-neural workflow, from neural induction to downstream differentiation.

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Topics

Pharmacology

Cell Culture & Characterization

In Vitro Assays

Implementing the Colony-Forming Unit (CFU) Assay As a Potency Assay for Hematopoietic Cell Therapy Products

Webinar Summary

Presenters

Colin Hammond

Sponsor

STEMCELL Technologies Inc.

Content Partners

Scientist.com

Topics

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