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NIST Workshop: Launch of the Rapid Microbial Testing Methods Consortium

magnifying glass magnifying microbes
Credit: N. Hanacek/NIST

NIST is establishing a Rapid Microbial Testing Methods (RMTM) Consortium to convene stakeholders in the pre-competitive space and address the need for measurements and standards, including reference materials, for rapid testing of microbial contaminants in regenerative medicine and advanced therapy products.  The purpose of this workshop is to launch and inform future directions of the RMTM Consortium.  Participants will learn about the state-of-the-art in rapid microbial testing methods, help to identify pressing measurement challenges and standards needs, and provide initial feedback on the proposed directions of the Consortium.  This workshop is open to all as an opportunity to provide input and learn about RMTM activities.  Future meetings of the Consortium will further refine and implement Consortium plans.

Speakers and Panelists

Printable PDF of Speaker Abstracts  and Speaker/Panelist Bios 

Speakers

  • SHENG LIN-GIBSON, Chief of the Biosystems and Biomaterials Division, NIST
  • SPENCER HOOVER, Independent Consultant
  • JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA
  • DAWN HENKE, Senior Scientific Program Manager, Standards Coordinating Body
  • KAI NESEMANN, Product Manager, Microbiology, Sartorius Lab Instruments GmbH & Co. KG 

Panelists

  • RICHARD HAMMOND, Technology Director, Cambridge Consultants Ltd.
  • TOM LEACH, Associate Director, Drug Product Process Engineering and Packaging, AstraZeneca
  • RICHARD MCFARLAND, Chief Regulatory Officer, ARMI|BioFabUSA
  • STACY SPRINGS, Senior Director of Programs; Executive Director Biomanufacturing Initiatives, Massachusetts Institute of Technology’s Center for Biomedical Innovation
  • RADHAKRISHNA TIRUMALAI, Principal Scientific Liaison, US Pharmacopeial Convention (USP)
  • CLAUDIA ZYLBERBERG, CEO, Akron Biotech

Agenda (Printable PDF) 

1:00pm - 5:00pm ET

Introductory Remarks

1:00 PM – 1:10 PM

Welcome and Overview RMTM Consortium and Workshop Goals

NANCY LIN, Leader of the Biomaterials Group, Biosystems and Biomaterials Division (BBD), Material Measurement Laboratory (MML), NIST

1:10 PM – 1:20 PM

Overview of NIST Advanced Therapy Program

Sheng Lin-Gibson, Chief of the BBD, MML, NIST

1:20 PM – 1:30 PM

Overview of NIST Microbial Metrology Program

SCOTT JACKSON, Leader of the Complex Microbial Systems Group, BBD, MML, NIST

 

Session 1: Challenges in Selecting and Applying a Rapid Microbial Test

Moderator: Jason Kralj, NIST

1:30 PM – 2:00 PM

Key Characteristics of Rapid Microbial Test Methods for Cell and Gene Therapies

Spencer Hoover, Independent Consultant

2:00 PM – 2:20 PM

FDA Requirements and Recommendations for Sterility Testing of Regenerative Medicine Therapies

JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA

2:20 PM – 3:05 PM

Panel Discussion: Measurement Challenges and Needs

Moderator: Scott Jackson, NIST

 

  • Spencer Hoover, Independent Consultant

 

  • Tom Leach, Associate Director, Drug Product Process Engineering and Packaging, AstraZeneca

 

  • CLAUDIA ZYLBERBERG, CEO, Akron Biotech

 

3:05 PM – 3:15 PM

BREAK

 

Session 2: Ongoing and New Efforts to Address Challenges

Moderator: Sandra Da Silva, NIST

3:15 PM – 3:20 PM

Introduction to Session 2

NANCY LIN, NIST

3:20 PM – 3:35 PM

Progress Toward Documentary Standards to Support Rapid Microbial Testing

Dawn Henke, Senior Scientific Program Manager, Standards Coordinating Body

3:35 PM – 3:55 PM

Rapid Detection of Bacteria and Fungi in ATMPs Prior Treatment – Validation of a Real-time PCR-based Test

Kai Nesemann, Product Manager, Microbiology, Sartorius Lab Instruments GmbH & Co. KG

3:55 PM – 4:45 PM

PANEL DISCUSSION: Potential Solutions and Paths for the Consortium

Moderator: Nancy Lin, NIST

 

  • JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA

 

  • RICHARD HAMMOND, Technology Director, Cambridge Consultants LTD

 

  • Richard McFarland, Chief Regulatory Officer, ARMI|BioFabUSA

 

  • STACY SPRINGS, Senior Director of Programs; Executive Director Biomanufacturing Initiatives, Massachusetts Institute of Technology’s Center for Biomedical Innovation

 

  • RADHAKRISHNA TIRUMALAI, Principal Scientific Liaison, US Pharmacopeial Convention (USP)

 

 

Concluding Remarks

4:45 PM – 5:00 PM

Summary and Next Steps

NANCY LIN and SCOTT JACKSON, NIST

 

 

Created August 3, 2020, Updated September 15, 2020