US 12,103,979 B2
N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
Neeraj Jagdish Agrawal, Natick, MA (US); Pavan Ghattyvenkatakrishna, Cambridge, MA (US); Sekhar Kanapuram, Thousand Oaks, CA (US); and Christopher James Sloey, Newbury Park, CA (US)
Assigned to Amgen Inc., Thousand Oaks, CA (US)
Appl. No. 16/607,673
Filed by AMGEN INC., Thousand Oaks, CA (US)
PCT Filed Apr. 27, 2018, PCT No. PCT/US2018/029981
§ 371(c)(1), (2) Date Oct. 23, 2019,
PCT Pub. No. WO2018/201064, PCT Pub. Date Nov. 1, 2018.
Claims priority of provisional application 62/492,020, filed on Apr. 28, 2017.
Prior Publication US 2020/0048367 A1, Feb. 13, 2020
Int. Cl. A61K 39/395 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 31/198 (2006.01); A61K 31/401 (2006.01); A61K 31/4172 (2006.01); A61K 38/05 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); C07K 5/06 (2006.01); C07K 16/18 (2006.01); C07K 16/40 (2006.01)
CPC C07K 16/40 (2013.01) [A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 31/198 (2013.01); A61K 31/401 (2013.01); A61K 31/4172 (2013.01); A61K 38/05 (2013.01); A61K 39/3955 (2013.01); A61K 39/39591 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); C07K 5/06 (2013.01); C07K 16/18 (2013.01)] 23 Claims
 
1. A liquid pharmaceutical composition comprising an antibody or an antigen-binding fragment thereof, a buffer, and at least one N-acetyl-dipeptide,
wherein the N-acetyl-dipeptide is N-acetyl-serine-arginine, N-acetyl-proline-arginine, or N-acetyl-proline-arginine-NH2;
wherein the antibody or antigen-binding fragment thereof is present in a concentration of at least 70 mg/ml; and
wherein the N-acetyl-dipeptide is present in a viscosity-reducing concentration.