Methods and formulations for reducing reconstitution time of lyophilized polypeptides
AssigneeGenentech, Inc.
InventorsFredric John Lim, Jacob Edward Luoma, Isidro Angelo Eleazar Zarraga, Christopher Michael Heynes
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Abstract
The present invention relates to methods and formulations useful for reducing the reconstitution time of lyophilized polypeptides.
Claims17
A liquid antibody formulation suitable for lyophilization, wherein the formulation comprises the antibody, a sugar, a diluent, and tert-butyl alcohol (TBA), wherein the amount of TBA in the liquid formulation is about 5%-6% by volume, wherein the amount of sugar in the liquid formulation is at a molar ratio of sugar:antibody of at least about 360:1, and
- wherein the time for reconstituting the antibody lyophilized in the presence of TBA is less than the time for reconstituting the same amount of the same antibody lyophilized in the absence of TBA.
A lyophilized antibody composition, wherein the lyophilized antibody composition is produced by preparing a liquid composition comprising the antibody and a sugar at a molar ratio of sugar:antibody of at least about 360:1,
- adding tert-butyl alcohol (TBA) to the liquid composition to form a liquid antibody/TBA mixture, wherein the amount of TBA in the liquid composition is about 5%-6% by volume,
- freezing the liquid antibody/TBA mixture, and
- lyophilizing the liquid antibody/TBA mixture to form a lyophilized antibody composition,
- wherein upon reconstitution of the lyophilized antibody composition with a diluent, the time for reconstituting the antibody lyophilized in the presence of TBA is less than the time for reconstituting the same amount of the same antibody lyophilized in the absence of TBA.
Dependencies are inferred from the claim text.