The University of Calgary (UCalgary) intends to purchase the BACT/ALERT 3D Dual Temperature System with the MYLA® Data Management Software from bioMérieux Canada, Inc. The BACT/ALERT 3D system is specifically designed for cell and gene therapy applications, offering fully automated microbial detection with real-time data monitoring and advanced quality control features. Its modular design and compact footprint make it ideally suited for GMP environments, while its ability to test a range of sample types—including cellular products, culture media, and final formulations—ensures flexibility in sterility testing. The Cell Therapy Lab at UCalgary currently uses the BACT/ALERT for sterility testing in GMP-compliant workflows. The UCalgary Riddell Centre for Cancer Immunotherapy requires the same system to ensure continuity and regulatory compliance during their transition to inhouse manufacturing. Additionally, to harmonize quality control (QC) testing across multiple academic sites, the Riddell Centre’s analytical methods are to be transferred to partner institutions that use the BACT/ALERT system. It is crucial for all participating sites to utilize the system with identical specifications to ensure comparable results, reduce variability, streamline collaborative efforts for clinical trials, and maintain consistency in GMP manufacturing processes. The BACT/ALERT system’s robust capabilities, including its proven reliability in GMP settings, real-time tracking, and precise microbial detection technology, make it indispensable for meeting regulatory requirements and supporting the broader collaborative goals of the Centre’s clinical trial initiatives. It is the Riddell Centre’s understanding that the bioMérieux BACT/ALERT 3D CGT system is the only instrument that meets their specific requirements for sterility testing in clinical CAR T cell manufacturing.
