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NIST 2024 Rapid Microbial Testing Methods Workshop Report

Published

Author(s)

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

Abstract

The NIST-led Rapid Microbial Testing Methods (RMTM) Consortium launched in 2020 to develop standards and measurement-based solutions to advance the use of RMTMs in advanced therapy products. NIST hosted 4th annual workshop on RMTMs to update the community on RMTM Consortium efforts and to work on Consortium deliverables. This report is to provide a summary of the finding from the workshop. Independent working sessions (1 h to 2 h in length) were hosted, Day 1 was open to the public and Day 2 was for Consortium members only. Parties involved in the workshop included advanced therapy producers, RMTM assay/instrument developers, and cell reference material producers.
Citation
Special Publication (NIST SP) - 1500-35
Report Number
1500-35

Keywords

Rapid microbial testing methods, sterility testing, biomanufacturing

Citation

Kralj, J. , Lin, N. , Parratt, K. , Servetas, S. , Henke, D. and Jackson, S. (2025), NIST 2024 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.1500-35, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=960437 (Accessed September 26, 2025)

Issues

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Created September 25, 2025
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