US 10,888,619 B2
Stable aqueous etanercept composition
Mark Manning, Johnstown, CO (US); and Brian Murphy, Fort Collins, CO (US)
Assigned to Coherus BioSciences, Inc., Redwood City, CA (US)
Filed by Coherus Biosciences, Inc., Redwood City, CA (US)
Filed on Jun. 14, 2019, as Appl. No. 16/441,103.
Application 16/441,103 is a continuation of application No. 15/917,333, filed on Mar. 9, 2018, granted, now 10,376,588.
Application 15/917,333 is a continuation of application No. 15/078,755, filed on Mar. 23, 2016, granted, now 9,943,601, issued on Apr. 17, 2018.
Application 15/078,755 is a continuation of application No. 13/654,950, filed on Oct. 18, 2012, granted, now 9,302,002, issued on Apr. 5, 2016.
Claims priority of provisional application 61/669,480, filed on Jul. 9, 2012.
Claims priority of provisional application 61/548,518, filed on Oct. 18, 2011.
Prior Publication US 2019/0290768 A1, Sep. 26, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 47/26 (2006.01); A61K 38/17 (2006.01); A61K 47/18 (2017.01); A61K 38/19 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); C07K 14/705 (2006.01); A61K 47/10 (2017.01); C07K 14/715 (2006.01); A61K 9/14 (2006.01); A61K 39/395 (2006.01); A61K 9/16 (2006.01); A61P 29/00 (2006.01); A61P 19/02 (2006.01); A61P 17/06 (2006.01)
CPC A61K 47/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 9/14 (2013.01); A61K 9/16 (2013.01); A61K 38/17 (2013.01); A61K 38/1793 (2013.01); A61K 38/191 (2013.01); A61K 39/39591 (2013.01); A61K 47/10 (2013.01); A61K 47/18 (2013.01); C07K 14/705 (2013.01); C07K 14/7151 (2013.01); A61P 17/06 (2018.01); A61P 19/02 (2018.01); A61P 29/00 (2018.01); C07K 2319/30 (2013.01)] 20 Claims
 
1. A stable aqueous pharmaceutical composition comprising
an aqueous carrier;
about 50 mg/mL etanercept, about 1% (w/v) sucrose, 0.26% (w/v) to 2% (w/v) mannitol or lysine; the aqueous carrier comprises a buffer, the composition is free of arginine and cysteine, the composition has a pH of about 6.0 to about 6.6, the composition has at least 90 wt. % correctly folded etanercept, the composition has less than 1 wt. % aggregates of etanercept, and
has at M3 or T2 or T4 no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 μm, and
wherein said composition contains less than 50 mM NaCl, and the combination of said sucrose and said mannitol or lysine stabilizes said etanercept in said stable aqueous pharmaceutical composition, wherein the composition has an osmolality from about 180 to about 420 mOsM, and wherein the etanercept is prepared by a mixed mode cation exchange chromatography and mixed mode anion exchange chromatography method resulting in less than 1 wt. % aggregates of etanercept.