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