Sterility testing of minimally manipulated cord blood products: validation of growth-based automated culture systems.

Abstract

BACKGROUND The St Louis Cord Blood Bank submitted a biologics license application for cord blood (CB) products processed by PrepaCyte-CB (BioE), supported with a validation study of a microbial detection system for product sterility testing (BACTEC-FX, Becton Dickinson). This article provides the validation approach followed to fulfill Food and Drug… (More)
DOI: 10.1111/trf.12229

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Cite this paper

@article{Akel2013SterilityTO, title={Sterility testing of minimally manipulated cord blood products: validation of growth-based automated culture systems.}, author={Salem M Akel and Joan Lorenz and Donna Regan}, journal={Transfusion}, year={2013}, volume={53 12}, pages={3251-61} }