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 is hosting the 4th annual workshop on RMTMs to update the community on RMTM Consortium efforts and to work on Consortium deliverables. Over the course of two days, independent working sessions (1 h to 2 h in length) will be hosted, with Day 1 open to the public and Day 2 for Consortium members only. This open, virtual workshop is free of charge. All interested parties are invited to Day 1, including advanced therapy producers, RMTM assay/instrument developers, and cell reference material producers. New members are being accepted into the Consortium.
Day 1 (4/11/2024) -- Open to the Public
9:45-10:00
Welcome Remarks and Workshop Overview
10:00-12:00
NGS Based Sterility Testing
Discuss the development of NGS-based analysis tools for microbial sterility testing in the biomanufacturing environment. Includes the development of custom reference genome/gene databases, bioinformatic pipelines, and standardized reporting formats.
12:00-1:00
Lunch
1:00-2:00
NIST RMTM Consortium Update
Overview of the NIST RMTM Consortium and updates on Working Group activities.
2:00-2:15
Break
2:15-3:30
Developments in RMTM Technology
3:30-3:45
Break
3:45-4:50
Roadmap for reference material characterization
Overview and discussion of a draft roadmap to optimize methods for total cell count and total genome count on microbial cell reference materials. Gather input to refine technical considerations in the roadmap.
4:50-5:00
Day 1 Wrap-Up
5:00
Adjourn
Day 2 (4/12/2024) -- Consortium Members ONLY
9:00-10:30
RMTM Interlaboratory study discussion
Interlaboratory Studies Working Group will present the plan (including draft experimental protocol and timeline) for the second RMTM interlaboratory study followed by open discussion and revisions.
10:30-10:45
Break
10:45-12:15
New Study: Quantification of total cell count for compendial organisms
Discussion of the technical plan for quantifying total cell count in USP <71> compendial microorganisms, including identification of appropriate strains, potential inclusion of commercial materials, and selection of measurement methods. This study will evaluate the method optimization roadmap for cell count in terms of fitness-for-purpose and robustness across microbial strains.
12:15-1:15
Lunch
1:15-3:15
Validation Strategies Workflow
Discussions on how to develop validation strategies for adopting new RMTMs in the current Good Manufacturing Practice (cGMP) biomanufacturing environment. Includes topics related to: what to sample, reference materials, experimental design, statistical analysis, and assessing analytical performance.
