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.
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.
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 Letter Agreement (LA)
No cost to join the Consortium
Notice of NIST's Rapid Microbial Testing Method Consortium
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.
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.
The RMTM Consortium Consists of 3 Working Groups
WG01 MISSION: The mission of the Reference Material Working Group (WG01) is to identify and facilitate the development, characterization, and qualification of reference materials (RMs) to support the wide adoption of new and existing Rapid Microbiology Test Methods (RMTMs) within the Advanced Therapy Industry.
WG02 MISSION: The mission of the Methods and Validation Schemes Working Group (WG02) is to develop a framework for the validation of methods to support the wide adoption of new and existing Rapid Microbiology Test Methods (RMTMs) by the Advanced Therapy Industry.
WG03 MISSION: The mission of the Interlaboratory Study Design and Implementation Working Group (WG03) is to design and implement interlaboratory studies to assess the analytical performance of various RMTMs while also evaluating the performance and fitness for purpose of candidate reference materials.
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
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
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