Welcome to the 2022 NIST 

Rapid Microbial Testing 

Methods Workshop

Graphic Credit: Natasha Hanacek

We will be using Slido for live polling 

during the workshop.

Please go to Sli.do #RMTM 

on your computer or mobile 

device.
2022 NIST Rapid Microbial Testing 

Methods Consortium (RMTM) Workshop

Tuesday, April 19, 2022

11:00 AM to 3:30 PM (ET)

Graphic Credit: Natasha Hanacek
Housekeeping

• This meeting is being recorded 

• Please join the meeting with your full name and organization 

• Please use the chat for comments/questions/feedback
Attendee Polls

How to Join the Consortium

• Submit a letter of interest

• Review and sign the agreement sent by NIST

• Connect to the shared drive, join working groups, contribute!
NIST and Rapid Microbial 

Testing Methods (RMTM) 

Consortium Overview

Sheng Lin-Gibson

April 19, 2022
Advanced Biometrology

Unprecedented measurement 

capabilities to quantify complex 

living systems and processes

Design-Build-Test-Learn

Tools, platforms, and 

data/knowledge to predictively 

engineer biological systems to 

accelerate innovation in R&D and to 

advance biomanufacturing

Standards

Standards and related infrastructure 

to accelerate technology 

development and translation/clinical 

use

Building the Next Generation Biometrology and Engineering Biology 

Capabilities to support U.S. Biotechnology Enterprise and Bioeconomy
NIST measurement services

Reference 

Materials

Reference 

Data

Documentary 

Standards

Calibration 

Services
NIST has been working with FDA and SCB to develop standards 

to support a growing regenerative medicine and advanced 

therapy industry

– Alliance for Regenerative Medicine; Q3 2021
NIST Consortia: Public-Private Partnership to address precompetitive challenges

NIST GENOME IN A 

BOTTLE (GIAB) 

CONSORTIUM 

NIST GENOME EDITING 

CONSORTIUM 

NIST FLOW CYTOMETRY 

STANDARDS 

CONSORTIUM

NIST RAPID MICROBIAL 

TESTING METHODS 

CONSORTIUM

Accelerates the 

adoption of quantitative 

flow cytometry in 

biomanufacturing

Develops measurement 

solutions and standards 

needed to increase 

confidence and reduce 

risks

Provides authoritative 

characterization of 

benchmark human 

genomes

Addresses measurements 

and standards needed to 

increase confidence in the 

use of rapid testing

https://www.nist.gov/mml/bbd
Advanced Therapy Products Need Modern Microbial 

Methods

Cell therapies (Living drugs)

Decreased manufacturing time

Short shelf-live

Critically needed for seriously ill patients

Manufacturing of advanced therapies, vaccines, and other 

biopharmaceutical products

Product sterility testing

USP <71> Based on culturing in broth for 14-21 days

6

21 days for sterility testing is too long!
Rapid Microbial Testing Methods (RMTM)

Example Rapid Methods

• Respiration (CO2 detection)

• ATP

• Solid phase cytometry

• PCR

• Raman/IR spectroscopy

• Flow cytometry

• Mass spectrometry

• Rapid methods must be shown non-inferior to culture methods

• Challenging to validate and adopt RMTMs (no rule book)

7

Results in <24 h up to 2-7 days
RMTM Consortium Timeline

Federal Register Notice

Jun 2020

Launch Workshop

Sep 2020

First Consortium Meeting & 

subsequent monthly WG 

meetings

Nov 2020

Initial results on commercial 

E. coli materials

Jan 2022

Open Workshop to share 

progress and inform future 

plans

Apr 2022

Initiate interlaboratory study 

Jun 2022 (anticipated)

8
Consortium Organization

NIST Team

• Scott Jackson

• Nancy Lin

• Tara Eskandari

• Sheng Lin-Gibson

• Jason Kralj

• Stephanie Servetas

• Kirsten Parratt

• Sandra Da Silva

• Joy Dunkers

• Monique Hunter

• Jennifer Dootz

• Shaswat Koirala

WG01 

Reference 

Materials

WG03 Interlab

Design and 

Implementation

WG02 Methods 

and Validation

Standards Coordinating Body

• Dawn Henke

• Melody Sanders

• Katie Zander

Nancy Lin

James Powell

Brian Beck

Scott Jackson

Cynthia Martino

Juan Diego Ospina

Jason Kralj

Huiping Tu

Sathya Janardhanan
30 Consortium Members (CRADA, no fee)

• Agilent Technologies

• Allele Biotechnology and Pharmaceuticals, 

Inc.

• AlloSource

• American Type Culture Collection (ATCC)

• Apsis Healthcare Systems, LLC

• bioMérieux

• Bionique Testing Laboratories, Inc.

• Bristol Myers Squibb

• Defense Biological Product Assurance 

Office, CBRND-EB, JPEO, DoD

• EMD Millipore Corporation (MERCK 

Kommanditgesellschaft auf Aktien)

• EzBiome Inc

• Gentech Biosciences

• George Washington University -

Computational Biology Institute

• Independent (Spencer Hoover)

• Independent (Vicki Barbur)

• Latham BioPharm Group 

• Microbiological Consulting, LLC

• Microbiologics, Inc.

• Microbiology Consultants, LLC

• NIH Clinical Center - Center for Cellular 

Engineering

• National Institute for Biological 

Standards and Control (NIBSC)

• National Institute for Innovation in 

Manufacturing Biopharmaceuticals 

(NIIMBL)

• Sartorius Aktiengesellschaft

• Siolta Therapeutics

• SmartGene GmbH

• United States Pharmacopeial 

Convention

• University of Delaware (Udel)

• U.S. Food and Drug Administration

• Vericel Corporation

• Weill Medical College of Cornell 

University

10

5 Advanced Therapy Producers

10 Assay/RM Manufacturers

6 Consultants/CROs

4 Government

3 Academia

2 Non-profit/Other