Evaluation of an automated blood culture detection system for sterility testing of cellular and gene therapy products

Cellular and gene therapy products have emerged in recent years as an important treatment modality at large academic medical centers; however, these products must be tested for microbial contamination to ensure product safety. Compared to the gold standard, agar-based solid media method, automated blood culture systems have emerged as a potential alternative method of sterility testing. Here, we evaluated the ability of an automated blood culture detection system (BacT/Alert Virtuo) to reliably detect diverse microorganisms, ranging from bacteria to mold, in two standard cellular and gene therapy product formulations. Our results support current evidence that the use of automated blood culture detection systems is a reliable alternative method of sterility testing for different formulations of cellular and gene therapy products.