IP Library › Granted Patent US 12,365,723
Granted Patent B2
US 12,365,723 · App. 16/917,701 · Granted Jul 22, 2025

Human plasma-derived IGG preparation enriched in anti-parvo B19 natural IGGS

Inventors: Lucia Gnauer (Ebersbrunn, AT); Harald Arno Butterweck (Vienna, AT); Theresa Bauer (Vienna, AT); Alfred Weber (Vienna, AT); Wolfgang Teschner (Vienna, AT); Hans-Peter Schwarz (Vienna, AT)
Assignee: Takeda Pharmaceutical Company Limited
C07K16/18B01D15/16B01D15/362B01D15/363B01D15/426B01D61/027C07K16/065C07K16/2803A61K2039/507B01D2311/2623C07K14/4717C07K2317/732
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Quick Facts
Patent No.
US 12,365,723
App. No.
16/917,701
Granted
Jul 22, 2025
Kind
B2
Abstract

Methods are provided for the manufacture of plasma-derived immunoglobulin G compositions highly enriched for anti-parvo B19 immunoglobulin G. The methods provided do not affect the manufacturing processes or capabilities for producing plasma-derived IgG therapeutics. Plasma-derived IgG compositions that are highly enriched for anti-parvo B19 immunoglobulin G are also provided. Methods for treating parvo B19 infections by administration of plasma-derived IgG compositions highly enriched for anti-parvo B19 immunoglobulin G are also provided.

Claims (25)

1. A method for treating a parvo B19 infection in a subject in need thereof, comprising administering a therapeutically effective amount of a plasma-derived immunoglobulin G composition comprising:

an enriched content of anti-parvo B19 immunoglobulin G, relative to the total content of immunoglobulin G, that is at least 3-fold greater than a quantified anti-parvo B19 immunoglobulin G content, relative to the total content of immunoglobulin G, in donor plasma prior to purification of the plasma-derived immunoglobulin G composition, and

a pharmaceutically acceptable stabilizing agent.

2. The method of claim 1 , wherein the enriched content of anti-parvo B19 immunoglobulin G is at least 5-fold greater than the quantified anti-parvo B19 immunoglobulin G content, relative to the total content of immunoglobulin G, in the donor plasma prior to purification of the plasma-derived immunoglobulin G composition.

3. The method of claim 1 , wherein the enriched content of anti-parvo B19 immunoglobulin G is at least 10-fold greater than the quantified anti-parvo B19 immunoglobulin G content, relative to the total content of immunoglobulin G, in the donor plasma prior to purification of the plasma-derived immunoglobulin G composition.

4. The method of claim 1 , wherein the titer of the anti-parvo B19 immunoglobulin G is at least 1500 IU/ml.

5. The method of claim 2 , wherein the titer of the anti-parvo B19 immunoglobulin G is at least 1500 IU/ml.

6. The method of claim 3 , wherein the titer of the anti-parvo B19 immunoglobulin G is at least 1500 IU/ml.

7. The method of claim 1 , wherein the pharmaceutically acceptable stabilizing agent is glycine.

8. The method of claim 2 , wherein the pharmaceutically acceptable stabilizing agent is glycine.

9. The method of claim 3 , wherein the pharmaceutically acceptable stabilizing agent is glycine.

10. The method of claim 1 , wherein the plasma-derived immunoglobulin G composition is prepared by a method comprising:

(A) binding polyclonal, plasma-derived immunoglobulin G to a first cation exchange material, wherein the immunoglobulin G comprises anti-parvo B19 immunoglobulin G;

(B) eluting at least 90% of the immunoglobulin G bound to the first cation exchange material in step (A) from the first cation exchange material, in a first cation exchange elution step, using a first cation exchange elution buffer having a pH of 4.0 to 10.0 and a conductivity of 3.0 mS/cm to 16.0 mS/cm, thereby forming a first cation exchange eluate;

(C) eluting immunoglobulin G remaining bound to the first cation exchange material after step (B), in a second cation exchange elution step, using a second cation exchange elution buffer having a pH of 4.0 to 10.0 and a conductivity of 100+80 mS/cm, thereby forming a second cation exchange eluate enriched in anti-parvo B19 immunoglobulin G.

11. The method of claim 10 , wherein the first cation exchange material is a weak cation exchange material.

12. The method of claim 10 , wherein the first cation exchange material is a carboxymethyl cation exchange resin.

13. The method of claim 10 , wherein the first cation exchange elution buffer has a pH of 7.0 to 9.5.

14. The method of claim 10 , wherein the first cation exchange elution buffer has a pH of 8.0 to 9.0.

15. The method of claim 10 , wherein the first cation exchange elution buffer has a conductivity of 5.0 mS/cm to 8.0 mS/cm.

16. The method of claim 10 , wherein the first cation exchange elution buffer has a pH of 8.5+0.2 and a conductivity of 5.0+1 mS/cm.

17. The method of claim 10 , wherein the second cation exchange elution buffer has a pH of 7.0 to 9.5.

18. The method of claim 10 , wherein the second cation exchange elution buffer has a pH of 8.0 to 9.0.

19. The method of claim 10 , wherein the second cation exchange elution buffer has a conductivity of 80 mS/cm to 150 mS/cm.

20. The method of claim 16 , wherein the second cation exchange elution buffer has a pH of 8.0 to 9.5 and a conductivity of 80 mS/cm to 120 mS/cm.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2021
From: BAXALTA GMBH; BAXALTA INCORPORATED
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 055189/0238 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 6, 2020
From: GNAUER, LUCIA; BUTTERWECK, HARALD ARNO; BAUER, THERESA; WEBER, ALFRED; TESCHNER, WOLFGANG; SCHWARZ, HANS-PETER
To: BAXALTA INCORPORATED; BAXALTA GMBH
Reel/Frame 053424/0612 →
Continuity (4)
Continuation 15385721 · Dec 20, 2016
Division 14213585 · Mar 14, 2014
Provisional Application 61794378 · Mar 15, 2013
Related Publication 20210054058A1 · Feb 25, 2021
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