RU-2026112373-A - IgA-DEPLETED IMMUNOGLOBULIN-BASED FORMULATIONS

Inventors

• Тешнер, Вольфганг
• БУТТЕРВЕК, Харальд
• ГНАУЭР, Лусия
• НИЧ, Лена-Софи
• КЕЛБЛЬ, Бернхард
• БАУЭР, Тереза
• КАРНЬЮАЛ, Кристоф

Assignees

• ТАКЕДА ФАРМАСЬЮТИКАЛ КОМПАНИ ЛИМИТЕД

Dates

Publication Date

20260505

Application Date

20240926

Priority Date

20230926

Claims (20)

1. 1. A method for producing a shelf-stable pharmaceutical composition based on IgG, wherein the pharmaceutical composition contains no more than about 2 μg/ml IgA in an aqueous pharmaceutically acceptable carrier, wherein the composition has a property selected from
2. (i) a pH of about 4.4 to about 4.9;
3. (ii) glycine concentrations from about 0.1 M to about 0.4 M and
4. their combinations,
5. wherein the method includes
6. (a) performing an anion exchange step in an anion exchange precursor solution containing IgG, wherein the step comprises
7. (i) subjecting the anion exchange precursor solution to anion exchange chromatography in a single run through a first portion of the anion exchange medium contained in a first column and collecting a first anion exchange stream from the first column; and
8. (ii) optionally, after step (i), washing the anion exchange medium with a wash buffer, wherein from about 0.25 column volume to about 1 column volume of wash buffer is used for washing.
9. 2. The method according to claim 1, in which one run through the anion exchange medium is carried out in the first column and in the second column containing the second portion of the anion exchange medium, wherein the first and second columns operate in parallel mode, and the second anion exchange stream is collected from the second column.
10. 3. The method according to claim 1, wherein one run through the anion exchange medium is carried out in the first column and in the second column containing the second portion of the anion exchange medium, wherein the first and second columns operate in a sequential mode, and the second anion exchange stream is collected from the second column.
11. 4. The method according to any one of the preceding claims, wherein the IgG is loaded onto an anion exchange material with a maximum loading of about 70 mg/ml resin.
12. 5. The method according to any one of claims 1-4, wherein the first and second anion exchange streams are optionally combined.
13. 6. The method of any one of claims 1 to 5, wherein the pH of the anion exchange precursor solution is from about 6.2 to about 7.0, such as from about 6.4 to about 7.0, such as from about 6.7 to about 6.9, and the conductivity is from about 0.5 to about 2.5, such as from about 0.7 to about 1.5, such as from about 0.8 to about 1.0 mS/cm.
14. 7. The method according to any one of claims 1-6, wherein the protein concentration of the anion exchange flux is from about 3 g/L to about 15 g/L.
15. 8. The method according to any one of claims 1 to 7, wherein the wash buffer stream is combined with the anion exchange stream.
16. 9. The method according to any one of claims 1 to 8, wherein the anion exchange precursor solution is an eluate from a cation exchange step of an IgG-containing suspension (e.g. from precipitate G) preceding step (a).
17. 10. The method of claim 9, wherein the eluate from the cation exchange step preceding step (a) is an eluate from one or more cation exchange columns.
18. 11. The method according to claim 9, wherein the precursor solution for the cation exchange step is a mixture of dissolved precipitate G, solvent and detergent.
19. 12. The method of claim 11, wherein the solvent and detergent are a mixture of octoxynol 9, polysorbate 80 and tri-(n-butyl)phosphate or equivalents thereof.
20. 13. The method of claim 12, wherein octoxynol 9 or equivalent is present at a concentration of about 1.0 ± 0.5% (v/v); polysorbate 80 or equivalent is present at a concentration of about 0.3 ± 0.15% (v/v); and tri-(n-butyl)phosphate or equivalent is present at a concentration of about 0.3 ± 0.15% (v/v).