FIELD: medicine.
SUBSTANCE: group of inventions refers to medicine and concerns a stable aqueous pharmaceutical composition, where the composition contains (a) a monoclonal antibody in amount of 45 mg/ml to 55 mg/ml; (b) trehalose in amount of 50 mM to 70 mM and (c) sodium phosphate in amount of 22 mM to 28 mM, wherein the pH of said composition ranges from 5.9 to 6.5, where said antibody is bevacizumab. Group of inventions also relates to an industrial article for treating a malignant tumour in an individual comprising a container containing said composition; a method of producing said composition; method of treating a malignant tumour in an individual involving administering said composition.
EFFECT: group of inventions provides reduced formation of aggregates and reduced formation of tail dimers in antibody compositions.
42 cl, 2 ex, 7 dwg, 3 tbl
| Title | Year | Author | Number |
|---|---|---|---|
| ANTIBODY-BASED FORMULATIONS | 2015 |
|
RU2704611C2 |
| COMBINED THERAPY BY AFUCOSYLATED ANTIBODY FOR CD20 WITH ANTIBODY FOR VEGF | 2011 |
|
RU2615459C2 |
| ANTIBODY PREPARATION | 2008 |
|
RU2476238C2 |
| COMPOSITION CONTAINING ANTIBODY | 2010 |
|
RU2609658C2 |
| METHOD AND COMPOSITION FOR REDUCTION OF MICROMOLECULE AGGREGATION UNDER PHYSIOLOGICAL CONDITIONS | 2009 |
|
RU2563823C2 |
| COMBINED THERAPY WITH AFUCOSYLATED CD20 ANTIBODY AND mTOR INHIBITOR | 2011 |
|
RU2585489C2 |
| COMBINED THERAPY WITH TYPE II ANTI-CD20 ANTIBODIES IN COMBINATION WITH PROTEASOME INHIBITOR | 2008 |
|
RU2520757C2 |
| COMPOSITIONS OF ANTIBODIES | 2005 |
|
RU2426554C2 |
| AGENTS REDUCING B-CELL COUNT, INCLUDING CD20 ANTIBODIES OR FRAGMENTS THEREOF, FOR TREATING CHRONIC FATIGUE SYNDROME | 2009 |
|
RU2519229C2 |
| METHODS OF PURIFYING POLYPEPTIDES | 2011 |
|
RU2594163C2 |
