Hematopoietic Cell Therapy Products: Determining Potency and Stability

There are unique challenges when it comes to cell therapy products, including ensuring the reproducibility and consistency of product lots. These specific concerns arise from the inherent variability of the starting material, which often comes from multiple patients or donors. Before using these cells as therapy, the quality–including both purity and potency–of the final product must be established. This in turn requires reliable cell assays.

 

The best type of assay to measure the functionality of hematopoietic stem and progenitor cells (HSPCs) is an in vivo mouse model engraftment study; however, these types of assays are time-consuming, expensive, and difficult to evaluate. Therefore, the in vitro colony-forming unit (CFU) assay, which has been shown to correlate well with in vivo engraftment models, is recommended to evaluate the quality of HSPCs used in cell therapy. Several cord blood bank accrediting bodies (including AABB and FACT) now require pre-freeze CFU data from cord blood collection, as evidence of sample stability and to ensure there is minimal loss of HSPCs during processing and cryopreservation.

 

In this webinar, Dr. Jackie Damen of STEMCELL Technologies will explore the need for standardized potency assays for hematopoietic cell products and review recent publications that evaluate the effects of cryopreservation protocols on the potency of cell therapy products. Dr. Damen will define the CFU assay and explore its utility as part of the cell therapy workflow. She will also define simple steps that can help ensure standardization of the CFU assay, including the use of automated imaging and analysis of cultures.

 

Learning Objectives: