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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Autors principals:	Michael Snyder, Ashley Lawrence, Jane Reese, David Wald, Neil Anderson, Eric Ransom
Format:	Artigo
Idioma:	Inglês
Publicat:	American Society for Microbiology 2026-04-01
Col·lecció:	Microbiology Spectrum
Matèries:	sterility testing cellular therapy gene therapy automated blood culture detection automated growth detection bioMérieux
Accés en línia:	https://journals.asm.org/doi/10.1128/spectrum.02902-25
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