SCB Co-Convenes Rapid Microbial Testing Methodology (RMTM) Workshop
Washington, DC (April 11, 2018) — Yesterday, SCB, the National Institute of Standards and Technology (NIST), BioFabUSA, and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) hosted a workshop to gather input from the regenerative medicine community on advancing rapid microbial testing methodology (RMTM) technologies and standards for sterility testing.
More than 60 experts from academia, regulatory agencies, standards development organizations, and industry participated in the in-person workshop held at the NIST National Cybersecurity Center of Excellence. Discussion topics included gaps in current sterility testing methodologies, novel RMTM technologies, and related standards and regulatory guidance. Participants also broke into small groups to develop recommended technical strategies for incorporating novel RMTMs across the regenerative medicine community and to identify user requirement specifications to inform further RMTM technology advances.
While RMTMs are critical for assessing the quality and safety of regenerative medicine products, many available methodologies are not suitable for cell and gene therapeutic product testing. This workshop was held as a part of SCB’s efforts to drive the development of the RMTM standards and best practices that the regenerative medicine community needs today to employ fast, efficient, and reliable methods for measuring potentially harmful microbes in therapy products and for analyzing and validating testing results.
SCB will use the cross-community input gathered at this week’s workshop to develop a white paper—planned for publication in mid-2018—that recommends a risk-based strategy to replace growth-based sterility testing with more rapid techniques.