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METHOD AND COMPOSITION FOR REDUCING MACROMOLECULE AGGREGATION IN PHYSIOLOGICAL CONDITIONS
专利权人:
ДЖЕНЕНТЕК, ИНК.;Ф.ХОФФМАНН-ЛЯ РОШ АГ;ДЖЕНЕНТЕК, ИНК.
发明人:
ЛОБО Брайан,ЛО Сабрина,ВАКАНКАР Адитья,ВАНГ Ючанг Джон,ВОНГ Рита Л.,ГОЛЬДБАХ Пьер,МАЛЕР Ханис-Кристиан
申请号:
RU2011124527
公开号:
RU2011124527A
申请日:
2009.11.16
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A method of minimizing inflammation at the injection site during subcutaneous administration of a macromolecule, comprising adding to the composition containing the macromolecule, from 5% to 20% polyvinylpyrrolidone (PVP) having a molecular weight in the range from 2000 to 54000 daltons. 2. The method of claim 1, wherein the macromolecule is a protein. The method of claim 2, wherein the protein is an antibody. The method of claim 3, wherein the antibody is a therapeutic antibody. The method of claim 3, wherein the antibody is a diagnostic antibody. The method of claim 3, wherein the antibody is an anti-CD20 antibody. The method according to claim 6, where the antibody contains an antibody variant A, B, C, D, F, G, H or I, as shown in Table 1.8. The method according to claim 6, where the antibody contains an amino acid sequence selected from the group consisting of SEQ ID NO: 1-15.9. The method of claim 6, wherein the antibody comprises a light chain variable domain of SEQ ID NO: 1 and a heavy chain variable domain of SEQ ID NO: 2.10. The method according to claim 6, where the antibody contains the variable domain of the light chain of SEQ ID NO: 3 and the variable domain of the heavy chain of SEQ ID NO: 4.11 The method according to claim 6, where the antibody contains the variable domain of the light chain of SEQ ID NO: 3 and the variable domain of heavy chains of SEQ ID NO: 5.12. The method of claim 6, wherein the antibody comprises a full-length light chain of SEQ ID NO: 6 and a full-length heavy chain of SEQ ID NO: 7.13. The method of claim 6, wherein the antibody comprises a full-length light chain of SEQ ID NO: 6 and a full-length heavy chain of SEQ ID NO: 15.14. The method of claim 6, wherein the antibody comprises a full-length light chain of SEQ ID NO: 9 and a full-length heavy chain of SEQ ID NO: 10.15. The method of claim 6, wherein the antibody comprises a full-length light chain of SEQ ID NO: 9 and a full-length heavy chain of SEQ ID NO: 11.16. The me
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