Methods and compositions with reduced opalescence
AssigneeWyeth
InventorsPilarin Elizabeth Nichols, Donna L. Luisi
Life of this patent
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Abstract
Methods for reducing the opalescent appearance of a protein preparation by modifying the ionic strength of the preparation, as well as compositions, e.g., pharmaceutical compositions, of concentrated protein with decreased opalescence are disclosed. Purification methods which monitor and/or reduce the salt concentrations at selected steps are also disclosed.
Claims40
A method for decreasing the opalescence of an antibody preparation, the method comprising:
- (a) determining a second virial coefficient of an antibody in the antibody preparation;
- and
- (b) if the second virial coefficient of the antibody is negative, reducing the ionic strength of the antibody preparation such that the opalescence of the antibody preparation is reduced.
A method for reducing the formation of high molecular weight species in an antibody preparation, the method comprising:
- (a) providing an antibody preparation comprising an antibody determined to have a negative second virial coefficient;
- (b) reducing the ionic strength of the antibody preparation such that the high molecular weight species in the antibody preparation are reduced.
A method of decreasing the formation of high molecular weight species in an antibody preparation, the method comprising:
- (a) providing an antibody preparation comprising an antibody determined to have a negative second virial coefficient in 100 mM sodium chloride solution;
- (b) reducing the ionic strength in the antibody preparation such that the formation of high molecular weight species in the antibody preparation is reduced.
A method of improving the efficiency of a purification process of an antibody in an antibody preparation, the method comprising:
- evaluating whether the antibody in the antibody preparation has a negative second virial coefficient at one or more salt concentrations;
- reducing the ionic strength in the antibody preparation, such that the high molecular weight species in the antibody preparation is reduced, thereby improving the efficiency of a purification process of an antibody preparation.
Dependencies are inferred from the claim text.