Abstract
In recent years, Advanced Therapy Medicinal Products (ATMPs) have been adopted. One of the major differences from the conventional sterile pharmaceuticals is the very short time to administration; in some cases, it is only 2–3 days. For such products, rapid microbiological testing is necessary, and conventional culture-based sterility testing, which takes 14 days to obtain results, is a particularly significant challenge from the perspective of patient safety.
In this paper, the regulatory trends regarding microbial control for ATMPs by PIC/S, Japan, the U.S. and Europe are discussed.
Moreover, the application of advanced Rapid Microbiological Method (RMM：Rapid Microbiological Method) to the sterility testing for ATMPs is discussed. In this study, “High Sensitivity ATP Method,” which can directly measure ATP levels as low as those of single viable bacterial cells is used. The challenge with the ATP method is background ATP noise caused by mammalian cell-derived ATP. However, by combining suitable sample preparation methods such as the “pre-culture method” and the “cell-elimination method”, it is suggested that sterility test results can be obtained within a few hours to a few days.
