Interest in rFC and rCR, which are sustainable BET reagents, has been increasing year by year. Various organizations have been considering and evaluating the equivalence of recombinant reagents and conventional LAL reagents. In May 2025, recombinant reagents were officially listed in the USP as a method to perform the bacterial endotoxin test. As a result of these developments, consideration has begun to switch from LAL reagents to recombinant reagents, resulting in a growing interest in the suitability of recombinant reagents for use in automated analyzers to reduce inter-human variability in quality control using recombinant reagents and operational errors in processing multiple samples. We evaluated the suitability of our rCR reagent, PYROSTAR Neo+, for use in our fully automated, compact endotoxin measurement system, KLANOS. As a result, the measurement results obtained using the automated analyzer were found to have reduced inter-human variability and operational errors in processing multiple samples, compared to manual pipetting. In addition, comparative verification using various pharmaceutical samples showed results equivalent to those obtained using manual pipetting. These results show that, like LAL reagents, recombinant reagents can also be adapted to automated systems and are effective in reducing inter-human variability and operational errors in processing multiple samples.
Francis et al. (Thu,) studied this question.