The NIST Rapid Microbial Testing Methods (RMTM) Consortium addresses 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 consortium launch workshop, held on September 17, 2020, included presentations and panel discussions from subject matter experts. The workshop agenda, abstracts, and full recording are available on the workshop website.
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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 brings together experts across the regenerative medicine field including stakeholders in industry, academia and government to address this need.
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: