Report from the 2023 NIST-Hosted Workshop on Collaborative Efforts to Enable Adoption of Rapid Microbial Testing Methods for Advanced Therapy Products

Published

September 26, 2025

Author(s)

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

Abstract

On April 25, 2023, the National Institute of Standards and Technology (NIST) hosted a one-day hybrid workshop focused on bringing together organizations and working groups with the common goal of enabling validation and implementation of rapid microbial testing methods (RMTMs). The purpose of this workshop was to identify opportunities to leverage and coordinate ongoing and future efforts on RMTMs to accelerate their adoption for advanced therapy products. Based on workshop feedback, future areas of focus for the RMTM community to consider addressing include the need for data sharing – either via existing or new (e.g., interlaboratory study) datasets; increased awareness of existing regulatory and compendial initiatives, best practices, reference materials, and resources, and tools and measurement assurance strategies to advance the use of molecular-based RMTMs (e.g., sequencing and polymerase chain reaction). Increased collaborative efforts in these and other areas will promote the use of RMTMs and support improved safety for advanced therapy products.

Citation

Special Publication (NIST SP) - 1500-34

Report Number

1500-34

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.1500-34

Local Download

Keywords

Advanced therapy products, cell and gene therapy, consortium, microbial contamination, microbial detection, rapid methods, reference materials, regenerative medicine, standards, sterility testing, validation, workshop report

Citation

Servetas, S. , Henke, D. , Kralj, J. , Parratt, K. , Jackson, S. and Lin, N. (2025), Report from the 2023 NIST-Hosted Workshop on Collaborative Efforts to Enable Adoption of Rapid Microbial Testing Methods for Advanced Therapy Products, Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.1500-34, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=960408 (Accessed September 27, 2025)