Viral clearance by low ph hold
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsJena Daya, Valerie Ann Cusick, John Mattila
Life of this patent
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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.
Claims20
A method for purifying a peptide or protein from a sample containing IgG1 or IgG4, the method comprising:
- subjecting the sample to increasing ionic strength by addition of a salt, wherein a concentration of the salt is from about 1 mM to about 100 mM;
- subjecting the sample to an acidic pH condition, and
- subsequently maintaining the sample at an ionic strength condition and the acidic pH condition for at least about 15 minutes to reduce a quantity of active viral particles,
- wherein the sample comprises one or more impurities including the active viral particles.
A method for purifying a VEGF antagonist protein from a sample, the method comprising:
- subjecting the sample to increasing ionic strength by addition of a salt,
- subjecting the sample to an acidic pH condition, and
- subsequently maintaining the sample at an ionic strength condition and the acidic pH condition for at least about 15 minutes to reduce a quantity of active viral particles,
- wherein the sample comprises one or more impurities including the active viral particles.
Dependencies are inferred from the claim text.