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Cell Therapy Characterization Standardization Workshop

A NIST–FDA Joint Workshop

This workshop aims to support ongoing pre-standardization and standardization efforts for analytical methods used in cell therapy characterization and testing. Documentary standards are a critical aspect of the supporting infrastructure for advanced therapies. They can promote innovation and translation, help to secure supply chain and other infrastructure, and help to streamline regulatory review and reduce cost and time to market. Recent FDA guidance has established a standards recognition program for regenerative medicine therapies (SRP-RMT) and ongoing national and international pre-standardization and standardization efforts continue to drive standards development. Here we will discuss standardization efforts for several key analytical methods for cell therapy product characterization and testing including cell viability assays, cell activity assays, and assays related to cell therapy product safety including residual cells and sterility testing. We will conclude with a panel discussion on key considerations for cell therapy analytical method standardization. 

Draft agenda as of March 21, 2025
Day

Time

Session

Wednesday, 
June 11, 2025

9:00 am – 9:30 am

Setting the Stage:  Cell Therapy Characterization and Testing Standards Overview
Sumona Sarkar, NIST, and Judith Arcidiacono, FDA

 

9:30 am – 9:50 am

FDA Standards Recognition Program and Implications for CGT
TBA

 

9:50 am – 10:10 am

Standards Development and Coordination
TBA

 

10:10 am – 10:30 am

Sterility Testing of Cell Therapy Products
Nancy Lin, NIST
Update on the NIST Rapid Microbial Testing Methods Consortium

 

10:30 am – 11:00 am

Coffee break

 

11:00 am – 12:30 pm

Cell Viability Assay Standardization Efforts
Laura Pierce, NIST
Genera Requirements, Considerations and Validation Strategies for Fit-for-Purpose Cell Viability Analytical Methods

 

12:30 pm – 1:30 pm

Lunch

Wednesday,
June 11, 2025

1:30 pm – 2:30 pm

Cell Killing Assay Standardization Efforts
TBA
General Requirements and Considerations for Cell Killing Assays/Cell-Mediated Cytotoxicity Assays for CAR-Based Therapy Testing

 

2:30 pm – 3:30 pm

Characterization of iPSC-Based Cell Therapy Products
Lucilia Mouriès, Health & Environmental Sciences Institute (HESI)
Measurement of Residual iPSCs in Cell Therapy Products

 

3:30 pm – 4:00 pm

Coffee break

 

3:30 pm – 4:45 pm

Panel Discussion
Key Considerations for Cell Therapy Analytical Method Standardization 

 

4:45 pm – 5:00 pm

Wrap-Up

Created November 6, 2024, Updated March 21, 2025