Rapid microbial testing methods (RMTMs) have the potential to more quickly detect microbial contaminants in advanced therapy products, as compared to compendial methods that can take weeks. However, RMTMs are not widely adopted in the industry. NIST is hosting a workshop on challenges and standards-based solutions to promote the use of RMTMs for advanced therapy products and support the activities of the NIST RMTM Consortium.
The goals of the workshop are to identify measurement challenges and hurdles to the adoption of RMTMs for advanced therapy products and to share and obtain feedback on current and future efforts of the RMTM Consortium. Consortium activities to be discussed include development of methods to quantify microbial cell properties, including total cell count and total genome copy number; application of those methods to microbial whole cell reference materials, and interlaboratory studies to assess fitness for purpose of the reference materials. Expected outcomes include a shared knowledge of challenges and recent advances in RMTMs, an increased awareness of the NIST RMTM Consortium and its activities, and stakeholder feedback to help inform the Consortium work plan.
This open, virtual workshop is free of charge, and all interested parties are invited including advanced therapy producers, RMTM assay/instrument developers, and cell reference material producers. The workshop is a great opportunity to learn about Consortium progress and decide whether joining is right for you. New members are still being accepted into the Consortium.
Topic: CO2-Based Technologies Speaker: Felix Montero, Scientific Director-Health and Personal Care Business, bioMérieux Talk Title: TBD
1:35 PM-1:45 PM
Topic: Solid Phase Cytometry-Based Technologies Speaker: Felix Montero, Scientific Director-Health and Personal Care Business, bioMérieux Talk Title: Application of Solid Phase Cytometry for rapid microbial testing for advanced therapy products