US 10,376,582 B2
Buffer formulations for enhanced antibody stability
John Cini, Cranbury, NJ (US); Athena Nagi, Cranbury, NJ (US); and Maria Taddei, Cranbury, NJ (US)
Assigned to Outlook Therapeutics, Inc., Cranbury, NJ (US)
Appl. No. 15/25,088
Filed by Outlook Therapeutics, Inc., Cranbury, NJ (US)
PCT Filed Oct. 16, 2014, PCT No. PCT/US2014/060810
§ 371(c)(1), (2) Date Mar. 25, 2016,
PCT Pub. No. WO2015/057910, PCT Pub. Date Apr. 23, 2015.
Claims priority of provisional application 61/891,485, filed on Oct. 16, 2013.
Prior Publication US 2016/0235845 A1, Aug. 18, 2016
Int. Cl. A61K 39/395 (2006.01); C07K 16/24 (2006.01); A61K 9/08 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/08 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01); C07K 16/241 (2013.01); C07K 2317/51 (2013.01); C07K 2317/515 (2013.01); C07K 2317/52 (2013.01)] 82 Claims
 
1. A buffered antibody formulation, comprising an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 1 and a light chain comprising the amino acid sequence of SEQ ID NO: 2, a buffer comprising from about 0.7 mM to about 1.3 mM of an acetate salt, from about 200 mM to about 206 mM of mannitol, from about 16 mM to about 22 mM of glacial acetic acid, and from about 24 mM to about 28 mM of sodium chloride, and about 0.07% (v/v) to about 0.15% (v/v) of polysorbate 80, wherein the antibody formulation has a pH of from about 5.1 to about 5.3.