VIRAL CLEARANCE BY LOW PH HOLD
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United States of America
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Nov 21, 2024
app pub date -
Jul 19, 2024
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Jul 19, 2024
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Abstract
Methods for viral clearance using low pH hold based on a statistical design of experiment are provided. Several factors are evaluated to characterize the impacts of a low pH hold step for virus inactivation, including the factors of pH conditions, conductivity conditions, protein type, temperature, acid titrant, spike timing, and post-spike filtration. In addition to the effect of pH on virus inactivation, an increase in ionic strength through manipulating the conductivity can be a key component that influences virus inactivation kinetics.
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