NIST 2025 快速微生物检测方法研讨会报告

Jason G. KraljKirsten H. ParrattTyler S. LairdStephanie L. ServetasNancy J. LinDawn Henke This publication is available free of charge from:https://doi.org/10.6028/NIST.SP.1500-36 NIST Special Publication 1500NIST SP 1500-36NIST 2025 Rapid Microbial TestingMethods Workshop Report Jason G. KraljKirsten H. ParrattTyler S. LairdStephanie L. Servetas Dawn HenkeStandards Coordinating Body *Former NIST employee; all work for this publication was done while at NIST. This publication is available free of charge from:https://doi.org/10.6028/NIST.SP.1500-36 September 2025 NIST SP 1500-36September 2025 Certain equipment, instruments, software, or materials, commercial or non-commercial, are identified in thispaper in order to specify the experimental procedure adequately. Such identification does not imply This publication is intended to capture external perspectives related to NIST standards, measurement, and testing-related efforts. These external perspectives can come from industry, academia, government, and other NIST Technical Series Policies Copyright, Use, and Licensing StatementsNIST Technical Series Publication Identifier Syntax Publication History Approved by the NIST Editorial Review Board on 2025-09-23 How to Cite this NIST Technical Series PublicationKralj JG, Parratt KH, Laird TS, Servatas SL, Henke D, Jackson SA, Lin NJ (2025) NIST 2025 Rapid Microbial TestingMethods Workshop Report. (National Institute of Standards and Technology, Gaithersburg, MD), NIST SpecialPublication (SP) NIST SP 1500-36. https://doi.org/10.6028/NIST.SP.1500-36 Author ORCID iDs Jason G. Kralj: 0000-0003-4565-1176Kirsten H. Parratt: 0000-0002-2640-3276Tyler S. Laird: 0000-0003-2317-2895Stephanie L. Servetas: 0000-0002-4924-4511Nancy J. Lin: 0000-0002-6980-3288Dawn Henke: 0009-0006-6317-1765Scott A. Jackson: 0000-0003-4891-8323 Contact Informationnancy.lin@nist.gov100 Bureau Dr. MS 8543Gaithersburg, MD 20899 NIST SP 1500-36September 2025 Abstract In 2020, the National Institute of Standards and Technology (NIST)-led Rapid Microbial TestingMethods (RMTM) Consortium was established to develop standards and measurement-basedsolutions to facilitate the adoption of RMTMs in advanced therapy products. To update thecommunity on the Consortium's progress and work on its deliverables, NIST hosted its 5thannual workshop on RMTMs. This report summarizes the key findings from the workshop, Keywords Rapid microbial testing methods; Consortium; Sterility testing; Advanced therapy products; Celland gene therapy; Regenerative medicine; Molecular methods; Microbial cell reference NIST SP 1500-36September 2025 Table of Contents 1. Consortium and Workshop Overview..............................................................................................1 3. NIST RMTM Consortium Working Group 1 (WG1) – Reference Materials: Toward Microbial Cell 4. NIST RMTM Consortium Working Group 3 (WG3)- Interlaboratory Studies: Microbial ContaminantDetection Across Rapid Sterility Testing Methods - Preliminary Interlaboratory Study Findings............5 5. NIST RMTM Consortium Working Group 2 (WG2) - Methods: Tools to Support Next GenerationSequencing as a Rapid Sterility Method ..............................................................................................6 List of Tables Table 1. 2025 RMTM Workshop Agenda .............................................................................................2 List of Figures Fig. 1. Demographics of workshop registrants.....................................................................................1 NIST SP 1500-36September 2025 Acknowledgments This manuscript was edited with the assistance of Llama-4-Maverick-17B128E-Instruct-FP8(Llama), developed by Meta. Llama was used to refine language, improve clarity, and enhancereadability in accordance with the authors’ instructions. All content, scientific claims, and Author Contributions Kralj JG: Conceptualization, Writing—original draft, Writing—review & editing.Parratt KH:Conceptualization, Writing—original draft.Laird TS: Conceptualization, Visualization.ServetasSL: Conceptualization, Visualization, Supervision.Lin NJ: Conceptualization, Visualization, 1.Consortium and Workshop Overview NIST Rapid Microbial Testing Methods Consortium The National Institute of Standards and Technology (NIST) Rapid Microbial Testing Methods(RMTM) Consortium was established in 2020 to unite experts from across the regenerativemedicine field, including stakeholders from industry, academia, and government to address the Workshop Overview On April 8, 2025, NIST hosted its 5th annual workshop on RMTMs. The goal of this open, half-day virtual workshop was to discuss recent technological advances in the field of rapid sterility The workshop drew a diverse group of 308 registrants, with the largest group (36 %) comingfrom industry (Fig. 1). Other registrants represented academia, non-profits, federal and non-federal government agencies,