Key result
Q-Sepharose Fast Flow anion exchange chromatography consistently achieved a simian virus 40 log(10) reduction value of ≥4.7 across operational ranges, supporting bracketed generic validation.
Population
Simian virus 40 used as a model virus for evaluating viral clearance capacity in continuous cell…
Design
Preclinical
Authors
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Supports generic validation for anion exchange in bioprocessing; leaves open applicability across viruses and manufacturing scales.
Q-anion exchange chromatography consistently achieves ≥4.7 log(10) reduction of SV40, supporting the application of bracketed generic validation for this purification step.
Curtis et al. (2003) studied this question. Q-Sepharose Fast Flow (QSFF) chromatography was evaluated on SV40 log(10) reduction value (LRV). Q-Sepharose Fast Flow anion exchange chromatography consistently achieved a simian virus 40 log(10) reduction value of ≥4.7 across operational ranges, supporting bracketed generic validation.
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