Project: Methods and Processes for Assessing Cell Identity

Type: Standards Advancement Project

Partners: the SCB Cell Therapy and Gene Therapy Sector Working Groups

Description:

Accurate identification of cells ensures that the intended cells are incorporated into a therapeutic product, which is critical for enabling the success of the regenerative medicine manufacturing process and the safety and efficacy of the resulting treatment. However, there are multiple methods and processes for assessing cell identity, each with its own benefits, drawbacks, and special considerations. In addition, a lack of robust quantitative methods (e.g., for determining heterogeneity and purity) limits the ability to connect cell identity to critical quality attributes (CQAs). Developing a standard could help researchers and product developers identify the most effective assessment approach for their use cases and better understand factors that could influence their findings (e.g., environmental variations and heterogeneity in cell population).

SCB is coordinating development of a documentary standard on cell identification terminology and product-specific approaches to determining cell identity.

Anticipated Availability: TBD

Progress:

(learn more about the standards advancement process)

Conducting a Feasibility Assessment: In December 2021/January 2022, SCB convened a series of meetings with experts from multiple stakeholder groups to discuss barriers and opportunities for potential standard topics related to cell identification. Participants determined that a standard on cell identification terminology and product-specific approaches to determining cell identity was both high priority and feasible for standardization. SCB developed a feasibility report on the discussion outcomes and next steps for developing a standard covering these topics.

Established a Working Group: SCB assembled a working group to coordinate the standard advancement effort.

Preparing to Draft the Standard: The working group is currently identifying the best scope for the standard and preparing it to present to a standards developing organization (SDO) for development.

Get Engaged:

SCB needs subject matter experts like you to join the working group — contact SCB for more information.