Rapid Micro Biosystems, Inc. announced that it expects the commercial launch of the Growth Direct Rapid Sterility application by mid-year 2024. Sterility testing is the final quality check for microbial contamination before a pharmaceutical product is released for commercial sale and is typically performed in a facility that manufactures products such as biologics or sterile injectables. The Company has developed a novel, proprietary Rapid Sterility application for use with its Growth Direct system.

This innovative solution delivers time to organism detection (?TTD?) in as little as 12 hours and final time-to-result (?TTR?) in as little as one to three days. This capability represents a significant improvement over widely used traditional test methods, which generally require a 14-day endpoint incubation, and provides compelling differentiation when compared to current rapid sterility products. The Growth Direct Rapid Sterility application leverages the Company?s platform technology, providing customers with all the benefits they are accustomed to with the Growth Direct system.

These benefits include full automation, enhanced data integrity, reduced human error and lower hands-on labor costs. In addition, the company expects that the Growth Direct Rapid Sterility application will enable faster release of final pharmaceutical product, allowing manufacturers to benefit from faster time to market, less potential waste and reduced inventory and holding costs. The Growth Direct Rapid Sterility application delivers TTD in as little as 12 hours and final TTR in as little as one to three days across an expanded panel of stressed microorganisms most commonly found in biomanufacturing environments, inclusive of the U.S. Pharmacopeia (USP)<71> microorganisms. The application has been designed to meet a limit of detection of one colony forming unit (CFU) as directed by USP<1223>.

Commercial launch of the Growth Direct Rapid Sterility application is expected by mid-year 2024.