Project: Determining and Interpreting Cell Viability

Type: Standards Advancement Project

Partners: ISO/TC 276 and the SCB Cell Therapy, Gene Therapy, and Tissue Engineering Sector Working Groups

Description:

It is difficult for researchers to identify the most appropriate method (e.g., assay) for assessing cell viability within a given therapy or cell type due to a lack of consensus around measurements, terminology, and testing parameters. In addition, test methods can be difficult to interpret due to a lack of understanding of what assays measure and how measured parameters correlate with cell viability. Standards in this area could better enable researchers to select reproducible assays that yield accurate and precise cell viability results.

SCB is coordinating an ISO/TC 276 cell viability standard that defines key cell viability terminology and provides considerations for cell viability measurements, method selection, measurement process, data analysis, and reporting.

Anticipated Availability: 2025

Progress:

(learn more about the standards advancement process)

Established a Working Group: The working group’s efforts will build upon initial work soliciting feedback from SDOs and cell therapy companies on the terminology they use, as well as other discussions regarding cell viability standards.

Conducted a Feasibility Assessment: In April/May 2021, SCB organized a series of meetings of experts from multiple stakeholder groups to discuss barriers and opportunities for potential standard topics. SCB developed a feasibility report on the discussion outcomes and next steps for developing a standard in this area.

Initiated New ISO Standard Project and formalized a plan to advance the standard. SCB will continue to provide support to ISO/TC 276 WG 3 as the draft moves through the ISO standard development process.

Get Engaged:

SCB needs subject matter experts like you to join the working group. To help, please contact SCB.