US 12,421,324 B2
Methods and formulations for reducing reconstitution time of lyophilized polypeptides
Fredric John Lim, South San Francisco, CA (US); Jacob Edward Luoma, South San Francisco, CA (US); Isidro Angelo Eleazar Zarraga, Millbrae, CA (US); and Christopher Michael Heynes, South San Francisco, CA (US)
Assigned to GENENTECH, INC., South San Francisco, CA (US)
Filed by Genentech, Inc., South San Francisco, CA (US)
Filed on Jun. 3, 2022, as Appl. No. 17/832,463.
Application 17/832,463 is a division of application No. 16/420,974, filed on May 23, 2019, granted, now 11,377,505.
Application 16/420,974 is a continuation of application No. PCT/US2017/068024, filed on Dec. 21, 2017.
Claims priority of provisional application 62/438,232, filed on Dec. 22, 2016.
Prior Publication US 2022/0298263 A1, Sep. 22, 2022
Int. Cl. A61K 39/395 (2006.01); A61K 9/19 (2006.01); C07K 1/02 (2006.01); C07K 16/06 (2006.01); C07K 17/10 (2006.01)
CPC C07K 17/10 (2013.01) [A61K 9/19 (2013.01); C07K 1/02 (2013.01); C07K 16/065 (2013.01); C07K 2317/50 (2013.01); C07K 2317/94 (2013.01)] 17 Claims
 
1. 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.