US 11,891,431 B2
Removal of serine proteases by treatment with finely divided silicon dioxide
Wolfgang Teschner, Vienna (AT); Hans-Peter Schwarz, Vienna (AT); Ruth Madlener, Kennelbach (AT); Sonja Svatos, Berg (AT); Azra Pljevljakovic, Vienna (AT); and Alfred Weber, Vienna (AT)
Assigned to Takeda Pharm Limitedceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Nov. 24, 2020, as Appl. No. 17/103,618.
Application 15/151,302 is a division of application No. 14/296,319, filed on Jun. 4, 2014, granted, now 9,468,675, issued on Oct. 18, 2016.
Application 14/296,319 is a division of application No. 13/117,028, filed on May 26, 2011, granted, now 8,772,462, issued on Jul. 8, 2014.
Application 17/103,618 is a continuation of application No. 16/241,551, filed on Jan. 7, 2019, granted, now 10,875,906.
Application 16/241,551 is a continuation of application No. 15/619,346, filed on Jun. 9, 2017, granted, now 10,208,106, issued on Feb. 19, 2019.
Application 15/619,346 is a continuation of application No. 15/151,302, filed on May 10, 2016, granted, now 9,708,391, issued on Jul. 18, 2017.
Application 13/117,028 is a continuation in part of application No. 12/842,944, filed on Jul. 23, 2010, granted, now 8,304,524, issued on Nov. 6, 2012.
Application 12/842,944 is a continuation in part of application No. 12/789,365, filed on May 27, 2010, granted, now 8,993,734, issued on Mar. 31, 2015.
Claims priority of application No. 2010202125 (AU), filed on May 26, 2010.
Prior Publication US 2021/0139562 A1, May 13, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/06 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 38/17 (2006.01); A61K 47/18 (2017.01); C07K 1/30 (2006.01); C07K 1/36 (2006.01); A61K 39/395 (2006.01); A61K 35/16 (2015.01); B01D 15/12 (2006.01); B01D 15/36 (2006.01); B01D 15/42 (2006.01)
CPC C07K 16/065 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 35/16 (2013.01); A61K 38/1709 (2013.01); A61K 39/39525 (2013.01); A61K 47/183 (2013.01); B01D 15/12 (2013.01); B01D 15/362 (2013.01); B01D 15/363 (2013.01); B01D 15/424 (2013.01); C07K 1/30 (2013.01); C07K 1/36 (2013.01)] 19 Claims
 
1. A plasma-derived immunoglobulin G (IgG) composition comprising an IgG concentration of at least 10% and a serine protease concentration that induces hydrolysis of the substrate S-2266 at a rate of less than 5 nmol/ml×min, and wherein said composition is prepared by a method comprising the steps of:
(a) precipitating a cryo-poor plasma fraction, in a first precipitation step, with from about 6% to about 10% alcohol at a pH of from about 7.0 to 7.5 to obtain a first precipitate and a first supernatant;
(b) precipitating IgG from the first supernatant, in a second precipitation step, with from about 23% to about 27% alcohol at a pH of from about 6.7 to about 7.3 to form a second precipitate;
(c) suspending in a buffer the second precipitate to form a first suspension;
(d) contacting the first suspension with finely divided silicon dioxide (SiO2) under a solution condition suitable to bind a serine protease or serine protease zymogen, wherein the solution condition suitable to bind the serine protease or serine protease zymogen comprises a pH between about 4.5 and about 6.0 and a conductivity of between about 0.1 mS/cm and about 3 mS/cm; and
(e) separating the SiO2 from the first suspension to form a clarified suspension.