Dean migration mechanisms: facilitating the control of microbial contaminants in cell therapy product manufacturing.

ABSTRACT: Cell therapy products are rapidly transforming clinical practice, but their short shelf-lives and inability to undergo terminal sterilization create major challenges for sterility testing. Conventional rapid microbiological methods (RMMs) are hindered by the dense cellular background of therapeutic samples, which masks rare microbial contaminants and necessitates pre-analytical processing. Efficient separation of microorganisms from high-density cell suspensions is therefore a critical prerequisite for enabling real-time, in-process sterility assurance. Here, we systematically elucidate the Dean flow-dominated migration mechanism and determine its effective range for continuous, label-free separation of non-typical contaminants ≤ 5 μm in microchannels exceeding 40 μm in height. We demonstr

SUBMITTER: Tan J 

PROVIDER: S-EPMC12835003 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature