Robust scale-down models for chromatography process validation

Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

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The virus reduction of an affinity capture step was evaluated in a scale-down column format. The study was performed by a third-party viral testing laboratory in collaboration with a biopharmaceutical company. Viruses used: xMuLV and MVM.

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