Project: General requirements and considerations for cell-mediated cytotoxicity (cell killing) assays used in characterization and testing of CAR products for therapeutic use
Type: STANDARDS ADVANCEMENT PROJECT
Partners: ISO / TC 276 AND THE SCb cell therapy sector WORKING GROUP
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Description:
Cell-mediated cytotoxicity assays are used to measure the potential of a CAR T or NK cell to kill target cells. Cell-mediated cytotoxicity refers to the extent of damage or modification of function induced by an effector cell on a target cell. The appropriate selection of ex vivo monitoring methods that provide a measure of cell-mediated cytotoxicity is important in determining correlations between clinical and immunologic responses to a specific immunotherapy.
There are many significant challenges in the development of a suitable cell-mediated cytotoxicity assay. It is important for the assay that is designed to be highly specific and sensitive, as well as to be robust and reproducible to provide a quantitative measure of cell-mediated toxicity.
SCB is developing a document that specifies definitions and requirements for the selection and design of cell-mediated cytotoxicity assay for the characterization and testing of cellular therapeutic products. Additionally, the document will provide general considerations for validation and sources of variability in assay design for T-cell and NK cell-mediated cytotoxicity.
ANTICIPATED AVAILABILITY: May 2028
Progress:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Assembled a Cell Mediated Cytotoxicity Working Group: SCB has established a working group for this effort and initiated a biweekly working group meetings to coordinate the standard advancement effort.
Conducted Feasibility Assessment: In December 2022, SCB organized a meeting of 11 experts from multiple stakeholder groups to discuss barriers and opportunities for potential Evaluation of T-Cell Therapies standard topics. SCB developed a feasibility report on the assessment outcomes and planned next steps. However, to collected additional feedback from the community, this area of need was a major focus of the SCB/FDA/USP Workshop held in November 2023.
Begin Drafting Standard: SCB presented the standard to ISO in January 2025. SCB will coordinate the working group as it drafts the standard.
Get Engaged:
To join the working group or learn more about this initiative, please compete this survey or contact SCB