Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
Quick Links
Rapid microbial testing methods (RMTMs) have the potential to more quickly detect microbial contaminants in advanced therapy products, as compared to compendial methods that can take weeks. However, RMTMs are not widely adopted in the industry. NIST is hosting a workshop on challenges and standards-based solutions to promote the use of RMTMs for advanced therapy products and support the activities of the NIST RMTM Consortium.
The goals of the workshop are to identify measurement challenges and hurdles to the adoption of RMTMs for advanced therapy products and to share and obtain feedback on current and future efforts of the RMTM Consortium. Consortium activities to be discussed include development of methods to quantify microbial cell properties, including total cell count and total genome copy number; application of those methods to microbial whole cell reference materials, and interlaboratory studies to assess fitness for purpose of the reference materials. Expected outcomes include a shared knowledge of challenges and recent advances in RMTMs, an increased awareness of the NIST RMTM Consortium and its activities, and stakeholder feedback to help inform the Consortium work plan.
This open, virtual workshop is free of charge, and all interested parties are invited including advanced therapy producers, RMTM assay/instrument developers, and cell reference material producers. The workshop is a great opportunity to learn about Consortium progress and decide whether joining is right for you. New members are still being accepted into the Consortium.
SLIDES
| WELCOME | |
| 11:00 AM-11:15 AM | Opening Remarks and Brief Overview of NIST RMTM Consortium Nancy Lin (NIST) and Sheng Lin-Gibson (NIST) |
Session 1: Barriers and Potential Solutions to Adoption of RMTMsModerator: Nancy Lin | |
| 11:15 AM-11:30 AM | Topic: Regulatory Landscape Speaker: Margaret Riley, JD, Professor of Law, University of Virginia Talk Title: The Regulatory Context for Sterility Standards in Cell-Based Therapies |
| 11:30 AM-11:50 AM | Topic: End User Case Study on Implementation of RMTMs Speaker: Anna Lau, Ph.D., Chief Sterility Testing Services, NIH Clinical Center Talk Title: Creating GMP in an Academic Research Setting and Clinical Hospital Environment – Challenges and Lessons Learned at the NIH |
| 11:50 AM-12:10 PM | Topic: Barriers to Adoption of RMTMs Speaker: Michael Miller, Ph.D., President, Microbiology Consultants LLC Talk Title: Rapid Microbiological Methods: A Roadmap for Implementation |
| 12:10 PM-1:05 PM | Panel 1: Barriers and Potential Solutions to Adoption of RMTMs Moderator: Nancy Lin Panelists: Margaret Riley, Anna Lau, Michael Miller, Sheng Lin-Gibson, and Judith Arcidiacono (FDA) |
| BREAK 1:05 PM-1:15 PM | |
Session 2: Technologies and Tools for Rapid Microbial DetectionModerator: Jason Kralj (NIST) | |
| 1:15 PM-1:25 PM | Topic: ATP-Based Technologies Speaker: Jonathan Kallay, Senior Technology and Marketing Manager, Charles River Laboratory Talk Title: Celsis ATP Bioluminescence: From Cell Culture to Sterility |
| 1:25 PM-1:35 PM | Topic: CO2-Based Technologies Speaker: Felix Montero, Scientific Director-Health and Personal Care Business, bioMérieux Talk Title: TBD |
| 1:35 PM-1:45 PM | Topic: Solid Phase Cytometry-Based Technologies Speaker: Felix Montero, Scientific Director-Health and Personal Care Business, bioMérieux Talk Title: Application of Solid Phase Cytometry for rapid microbial testing for advanced therapy products |
| 1:45 PM-1:55 PM | Topic: PCR-Based Technologies Speaker: Alexandra Muller-Scholz, Manager PCR & Microbiology, Sartorius Talk Title: Rapid sterility of ATMPs prior treatment - Validation of a qPCR-based test |
| 1:55 PM-2:05 PM | Topic: Raman-Based Technologies Speaker: Oliver Valet, Founder and Managing Director, mibic GmbH & Co. KG Talk Title: Fast Automated Raman spectroscopic Detection and Identification of microbial Contamination |
| BREAK 2:05 PM-2:15 PM | |
| 2:15 PM-2:35 PM | Topic: Consortium Directions Speaker: Scott Jackson, NIST Talk Title: Current Progress and Activities of the NIST RMTM Consortium |
| 2:35 PM-3:25 PM | Panel 2: Technologies and Tools for Rapid Microbial Detection Moderator: Scott Jackson Panelists: Jonathan Kallay, Alexandra Muller-Scholz, Felix Montero, Oliver Valet, Kevin Wheeler (AlloSource) |
| CLOSING | |
| 3:25 PM-3:30 PM | Closing Remarks Scott Jackson and Nancy Lin |
Recordings
Session 1
Session 2