	US 12,144,861 B2
	Pharmaceutical product with increased stability comprising immunoglobulins
Renzo Pedrussio, Koeniz (CH); and Regula Styger, Bern (CH)
Assigned to CSL Behring AG, Bern (CH)
Appl. No. 15/532,378
Filed by CSL BEHRING AG, Bern (CH)
PCT Filed Dec. 3, 2015, PCT No. PCT/EP2015/078482 § 371(c)(1), (2) Date Jun. 1, 2017, PCT Pub. No. WO2016/087569, PCT Pub. Date Jun. 9, 2016.
Claims priority of application No. 14196069 (EP), filed on Dec. 3, 2014.
Prior Publication US 2018/0264111 A1, Sep. 20, 2018
Int. Cl. A61K 39/395 (2006.01); A61M 5/00 (2006.01); B65D 25/14 (2006.01); B65D 75/36 (2006.01); B65D 81/26 (2006.01); B65D 81/30 (2006.01); C07K 16/00 (2006.01)

CPC A61K 39/39591 (2013.01) [A61M 5/002 (2013.01); B65D 25/14 (2013.01); B65D 75/36 (2013.01); B65D 81/268 (2013.01); B65D 81/30 (2013.01); C07K 16/00 (2013.01); C07K 2317/10 (2013.01); C07K 2317/21 (2013.01); C07K 2317/94 (2013.01)]

31 Claims

1. A pharmaceutical product comprising an air-tight packaging comprising: (a) a pre-filled polymer syringe barrel comprising a polyclonal immunoglobulin solution comprising about 15% (w/v) to about 30% (w/v) IgG and one or more stabilizers, and (b) an oxygen scavenger, wherein the polyclonal immunoglobulin solution does not comprise the oxygen scavenger, wherein the polyclonal immunoglobulin solution is stable over a period of at least 24 months at 25° C. in the polymer syringe barrel, and wherein the polyclonal immunoglobulin solution has a lower absorbance at 350 nm and a lower anticomplementary activity (ACA) after 24 months at 25° C. in the polymer syringe barrel than that of an identical polyclonal immunoglobulin solution stored under identical conditions in a glass vial under inert gas.