Project: Rapid Microbial Testing Methods
Type: Standards Advancement Project
PARTNERS: National Institute of Standards and Technology (NIST), ARMI|BioFabUSA, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), ISO / TC 276, ASTM International Committee F04, and the SCB Cell Therapy and Tissue Engineering Sector Working Groups
Get Involved:Accepting new working group members
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DESCRIPTION:
Current compendial methods for detecting viable microbes in commercially manufactured pharmaceuticals have a number of limitations for implementation in cell or gene therapy production. These limitations include the need for more rapid results and in-line process testing capability, inability to detect or identify certain microbes, and unsuitability for large manufacturing volumes. Developing standards for validating and implementing rapid, efficient, and reliable microbial testing methods will help manufacturers better assess the quality and safety of products and allow treatments to be administered more quickly.
SCB established a rapid microbial testing methods (RMTM) working group and is coordinating its support of three separate standards advancement efforts. There are approximately 30 individuals in the working group, representing 5 academic institutions, 3 government institutions, and 11 industry organizations.
Anticipated Availability: 2022-2023
PROGRESS:
(learn more about the standards advancement process)
Note: Projected start dates are estimates only. Development of a standard depends on SDO timelines, which can vary.
Convened RMTM Workshop: SCB, NIST, ARMI|BioFabUSA, and NIIMBL hosted a workshop in April 2018 to solicit inputs from the regenerative medicine community on advancing RMTM technologies and standards.
Drafting an RMTM Validation Standard: SCB is coordinating the drafting of an ISO standard to create a flexible, risk-based framework for validating RMTM methods. The standard was accepted as an approved work item (AWI) at the June 2019 (ISO/CD 24190: Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses). The draft has undergone several rounds of revision and was submitted for final voting in early 2022.
Supporting Development of ASTM RMTM Scaffold Standard: The working group is developing an ASTM standard for RMTM requirements for therapies involving scaffolds. The project was accepted as an official work item in ASTM F04.45 (WK70143: New Guide for Sampling Methods of Tissue Engineered Medical Products (TEMPs) for Sterility Assurance) in November 2018 and is undergoing drafting.
GET ENGAGED:
SCB needs subject matter experts like you to support the development of these standards. To help, please contact SCB.