US 12,545,703 B2Granted

Method to produce an immunoglobulin preparation with improved yield

AssigneeTakeda Pharmaceutical Company Limited

InventorsLeopold Bruckschwaiger, Sonja Svatos, Julia Nuernberger, Wolfgang Teschner, Harald Butterweck, Hans-Peter Schwarz, Thomas Gundinger, Bernhard Koelbl, Reinhard Grausenburger, Azra Pljevljakovic

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Abstract

The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.

Claims20

Dependent claims

A method for preparing an enriched IgG composition from plasma, the method comprising the steps of:

(a) precipitating a cryo-poor plasma fraction, in a first precipitation step, with from 6% to 10% ethyl alcohol at a pH of from 7.0 to 7.5 to form a first precipitate and a first supernatant;
(b) precipitating IgG from the first supernatant, in a second precipitation step, with from 22% to 25% ethyl alcohol at a pH of from 6.7 to 7.3 to form a second precipitate;
(c) suspending the second precipitate to form a first suspension;
(d) mixing fumed silica with the first suspension formed in (c) for at least 30 minutes;
and
(e) separating a solubilized portion of the first suspension mixed with fumed silica in step (d) from a non-solubilized portion of the first suspension, thereby forming an enriched IgG composition.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 17/473,910Filed 13 Sep 2021 · continuation
Priority: AU 201020212526 May 2010
Published: US 2021/0403504 A130 Dec 2021
Granted: 10 Feb 2026
Term ends: Not estimatedThe source records don’t support an estimate.

Classification29 codes

C07K 1/36
Extraction; Separation; Purification: by a combination of two or more processes of different types
A61K 9/0019
Galenical forms characterised by the site of application: injectable compositions; Intramuscular, intravenous, arterial, subcutaneous…
A61K 9/0026
Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in…
A61K 9/08
Medicinal preparations characterised by special physical form: solutions

Family

Application12/789,365Parent of this continuation · filed 27 May 2010
Application13/653,332Parent of this continuation · filed 16 Oct 2012
Application14/309,668Parent of this continuation · filed 19 Jun 2014
US 8,940,877 B2Parent of this continuation · filed 27 Jan 2015
US 8,993,734 B2Parent of this continuation · filed 31 Mar 2015
Application15/807,512Parent of this continuation · filed 8 Nov 2017
US 2021/0403504 A1Pre-grant publication · published 30 Dec 2021
US 11,136,350 B2Parent of this continuation
US 2011/0293638 A1Published application
US 2013/0101579 A1Published application
US 2015/0133644 A1Published application
US 2018/0118782 A1Published application
US 12,545,703 B2This patent

From the US filing history. Foreign family members aren’t listed.