Viral clearance by low ph hold
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsJena Daya, Valerie Ann Cusick, John Mattila
Life of this patent
Estimating the term…
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.
Claims31
A method for purifying a peptide or 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, and
- subsequently maintaining the sample at the ionic strength condition and the pH condition for at least about 15 minutes to inactivate a quantity of viral particles;
- wherein the sample comprises one or more impurities including the viral particles.
A method of producing a preparation comprising a protein of interest and a reduced amount of viral particles from a sample having the protein of interest and an infectious viral particle, comprising:
- subjecting the sample to a pH of greater than of about 3.6;
- subjecting the sample to an increase in ionic strength condition by addition of a salt to the starting solution;
- and
- maintaining the sample at the pH and ionic strength condition for an appropriate amount of time to produce the preparation comprising the protein of interest and the reduced amount of infectious viral particles.
Dependencies are inferred from the claim text.