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NIST Rapid Microbial Testing Methods Consortium

Summary

The NIST Rapid Microbial Testing Methods (RMTM) Consortium has been established to address the need for measurements and standards, including reference materials, to increase confidence in the use of rapid testing for microbial contaminants in regenerative medicine and advanced therapy products. 

CONSORTIUM LAUNCH

A virtual half-day workshop was held on September 17, 2020 to launch the consortium.  This open workshop included presentations and panel discussions from subject matter experts, introduced the RMTM Consortium, and initiated the discussion of potential consortium directions.  The workshop agenda, abstracts and full recording are available on the workshop website

MEMBER BENEFITS 

  • Access to a neutral forum to address pre-competitive needs 

  • Participation in the development of reference materials, methods and protocols, and interlaboratory studies  

  • Access to tools developed by the Consortium ahead of public release 

  • Institutional representation on Consortium steering committee       

BECOME A MEMBER  

  • Complete the Letter of Interest Form

  • Participants will sign a Cooperative Research and Development Agreement (CRADA); Federal agencies may join under a Memorandum of Understanding (MOU) 

  • No cost to join the Consortium   

Notice of NIST's Rapid Microbial Testing Method Consortium 

Description

RMTM Identifier
Credit: Natasha Hanacek

The safety and quality of advanced therapies, including cell therapy, gene therapy, and tissue engineered products, must be maintained prior to patient administration. The culture-based compendial methods currently used to assess product purity (specifically to ensure absence of microbial contamination) typically take weeks, which is inadequate for patients in urgent need of life-saving therapies. These methods are also incompatible with products that have a limited shelf-life and cannot meet good manufacturing practices required in process control and release testing. Alternative rapid microbial testing methods are needed to ensure fit for purpose safety assessments for this broad class of advanced therapeutics. The NIST RMTM Consortium aims to bring together experts across the regenerative medicine field including stakeholders in industry, academia and government to address this need.  

CONSORTIUM GOALS 

  • Establish a repository of relevant microorganisms and help design fit for purpose microbial cell reference materials based on the repository 

  • Develop an inventory of potential measurement methods and protocols for rapid microbial testing for regenerative medicine products 

  • Design interlaboratory studies based on candidate reference materials to support the development of best practices and standard methods 

CONSORTIUM ORGANIZATION  

  • In coordination with the Consortium steering committee, Working Groups will be established to meet the Consortium goals 

CONSORTIUM IMPACT 

This consortium is expected to lead to measurement assurance tools for RMTM and increased confidence in their use for advanced therapy products due to: 

  • Stakeholder input into the design of microbial reference material(s) 

  • Data from interlaboratory studies to support development of best practices and standard methods  

  • Improved rapid microbial measurement capabilities 

CONSORTIUM MODEL 

  • Convenes industry, academia, and government to identify and address measurement and standards needs across the rapid microbial testing methods field 

  • Enables members to work with NIST to develop measurement solutions and standards 

  • Leverages NIST expertise in measurement science, standards development, reference materials, technology development, and basic research 

  • Collaborates with related programs at other organizations  

WHY NIST 

  • Cross-disciplinary expertise in engineering and the physical, information, chemical, and biological sciences 

  • As a non-regulatory agency of the U.S. Department of Commerce, NIST does not impose standards; standards are accepted by consensus 

  • Neutral convener for industry consortia, standards development organizations, federal laboratories, universities, public workshops, and interlaboratory comparability testing 

Created June 25, 2020, Updated October 27, 2020