NIST 2025 Rapid Microbial Testing Methods Workshop Report

Published

September 26, 2025

Author(s)

Jason Kralj, Kirsten Parratt, Tyler Laird, Stephanie Servetas, Nancy Lin, Dawn Henke, Scott Jackson

Abstract

In 2020, the National Institute of Standards and Technology (NIST)-led Rapid Microbial Testing Methods (RMTM) Consortium was established to develop standards and measurement-based solutions to facilitate the adoption of RMTMs in advanced therapy products. To update the community on the Consortium's progress and work on its deliverables, NIST hosted its 5th annual workshop on RMTMs. This report summarizes the key findings from the workshop, which was held as a single-day virtual event featuring external speakers. The workshop brought together a diverse group of stakeholders, including advanced therapy producers, developers of RMTM assays and instruments, and producers of cell reference materials.

Citation

Special Publication (NIST SP) - 1500-36

Report Number

1500-36

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.1500-36

Local Download

Keywords

Rapid Microbial Testing Methods Consortium, Regenerative Medicine, Cell therapy, Gene therapy, Sterility testing

Citation

Kralj, J. , Parratt, K. , Laird, T. , Servetas, S. , Lin, N. , Henke, D. and Jackson, S. (2025), NIST 2025 Rapid Microbial Testing Methods Workshop Report, Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.1500-36, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=960335 (Accessed September 28, 2025)