Cellular-based products are collected via different procedures offering diverse sources of contamination. Cellular therapy (CT) accrediting organizations such as AABB and the Foundation for Accreditation of Cellular Therapy recommend microbial testing for CT products. However, studies describing sterility testing of CT products are scarce and most of them have not been published. This session will discuss the importance of standardizing methods for CT product sterility testing. Current regulatory requirements, including the new FDA guidance for validation of automated methods, will be reviewed. Speakers will share their experiences with the validation and/or implementation of microbial testing for CT products at their institutions, including the use of automated methods.