Report from the 2022 NIST Rapid Microbial Testing Methods (RMTM) Workshop

Published

August 15, 2023

Author(s)

Stephanie Servetas, Nancy Lin, Nadratun Chowdhury, Scott Jackson, Jason Kralj, Sheng Lin-Gibson, Melody Sanders, Tara Eskandari

Abstract

Safety and quality of advanced therapies, including cellular, gene, and tissue-engineered medical products, is paramount for success of these products. Sterility assurance testing confirming the absence of microbial contamination in advanced therapy products is critical to establishing safety before patient dosing. To date, culture-based compendial methods are employed as the gold standard for sterility testing of pharmaceutical products. However, for advanced therapy therapy products, the required cultivation period (e.g., 14 days or more) is incompatible with the short (e.g., 2 days) product shelf life and jeopardizes healthcare outcomes for critically ill patients who need these lifesaving therapies. Alternative rapid microbial testing methods are increasingly being evaluated to reduce test result turnaround time for advanced therapies, but are not yet widely adopted. NIST hosted a Rapid Microbial Testing Methods (RMTMs) Workshop on April 19, 2022 to address overarching themes relevant to the need to implement rapid microbial testing methods. The workshop's goals were to identify measurement challenges and hurdles to adopting RMTMs for advanced therapy products and to share and obtain feedback on future efforts of the RMTM Consortium. To this end, subject matter experts from relevant legal, regulatory, and scientific/technological spaces were invited to give presentations related to two broad themes: 1. Barriers and Potential Solutions to Adoption of RMTMs, and 2. Technologies and Tools for Rapid Microbial Detection. Invited speakers also participated in panel discussions that actively engaged audience members via live polling during facilitated and impromptu discussions. This virtual workshop collectively served as a venue for shared knowledge and learning on the state of the field for RMTMs and hurdles in their broad adoption, consequently benefiting a diverse group of stakeholders. Additionally, the workshop promoted greater awareness of the NIST RMTM Consortium and its activities. Summaries of the presentations, discussion, and poll results are presented within this report.

Citation

Special Publication (NIST SP) - 1292

Report Number

1292

NIST Pub Series

Special Publication (NIST SP)

Pub Type

NIST Pubs

Download Paper

https://doi.org/10.6028/NIST.SP.1292

Local Download

Keywords

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

Citation

Servetas, S. , Lin, N. , Chowdhury, N. , Jackson, S. , Kralj, J. , Lin-Gibson, S. , Sanders, M. and Eskandari, T. (2023), Report from the 2022 NIST Rapid Microbial Testing Methods (RMTM) Workshop, Special Publication (NIST SP), National Institute of Standards and Technology, Gaithersburg, MD, [online], https://doi.org/10.6028/NIST.SP.1292, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=936634 (Accessed November 20, 2024)