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

Workshop Goal

Identify opportunities for leveraging and coordinating ongoing and future efforts on rapid microbial testing methods (RMTMs) to accelerate the validation and adoption of RMTMs in advanced therapy products. 

Workshop Overview

RMTM Identifier
Credit: Natasha Hanacek

Traditional methods for assessing contamination in pharmaceutical products take weeks, but emerging advanced therapy products require more rapid results.  Rapid microbial testing methods (RMTMs) are available but have not been widely adopted, due in part to the need for manufacturers to independently validate rapid microbial methods as well as the lack of tools to support this validation.  In 2020, NIST established the RMTM Consortium to convene stakeholders in the pre-competitive space and develop measurement solutions and standards that increase confidence in the use of RMTMs.  Outside of NIST, other organizations are similarly focusing on tools and solutions to support the use of rapid microbial methods for sterility and adventitious agent testing.  This workshop will bring together organizations including the NIST RMTM Consortium, the Standards Coordinating Body (SCB), the United States Pharmacopeia (USP), the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and others - to share their current and future activities. Together, we will discuss how to support one another, leverage and align activities, and identify opportunities for collaboration to accelerate the adoption of RMTMs in the advanced therapy community and beyond.  This free one-day, hybrid workshop is open to all.


9:00 AM

Welcome and Opening Remarks

9:20 AM

Keynote Presentation:
- Veera Dheenadhayalan, Director of Biosafety at AstraZeneca

9:55 AM

Invited Presentations:
- Huiping Tu, USP
- Fred Ayers, Eli Lilly (Topic: PDA)
- Jennifer Mantle, NIIMBL

10:40 AM


10:55 AM

Panel Discussion: Rapid Microbial Methods Beyond Regenerative Medicine

12:00 PM

Lunch (on your own)

1:30 PM

Invited Presentations:
- Siemon Ng, Notch Therapeutics (Topic: Advanced Virus Detection Technologies Interest Group)
- Stacy Springs, MIT (Topic includes: Consortium on Adventitious Agent Contamination in Biomanufacturing)
- Allison Scott, MicronView (Topic: Modern Microbial Methods Collaboration)
- NIST Rapid Microbial Testing Methods Consortium
- Dawn Henke, Standards Coordinating Body

2:50 PM


3:05 PM

Breakout Sessions (virtual and in person)

4:05 PM


4:15 PM

Reports from Breakout Sessions

4:55 PM

Concluding Remarks

5:00 PM


Keynote Speaker:

  • Veera Dheenadhayalan, Director Biosafety at AstraZeneca

Invited Speakers:

  • Huiping Tu, USP
  • Fred Ayers, Eli Lilly
  • Jennifer Mantle, NIIMBL
  • Siemon Ng, Notch Therapeutics
  • Stacy Springs, MIT
  • Allison Scott, MicronView
  • Dawn Henke, Standards Coordinating Body
  • NIST Rapid Microbial Testing Methods Consortium
Created February 22, 2023, Updated March 20, 2023