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

ABSTRACT Sterility testing of cellular and gene therapy products is required to ensure safe infusion for the recipient. Sterility testing is often performed using broth-based media per the biopharmaceutical compendial USP <71> method. Automated blood culture systems have emerged as a potential alter...

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Hoofdauteurs: Michael Snyder, Ashley Lawrence, Jane Reese, David Wald, Neil Anderson, Eric Ransom
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: American Society for Microbiology 2026-04-01
Reeks:Microbiology Spectrum
Onderwerpen:
sterility testing
cellular therapy
gene therapy
automated blood culture detection
automated growth detection
bioMérieux
Online toegang:https://journals.asm.org/doi/10.1128/spectrum.02902-25
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