FIELD: biotechnology.
SUBSTANCE: invention relates to biotechnology and is a stable antibody-containing formulation which is suitable for subcutaneous administration, comprising amino acid-aspartate or basic amino acid-glutamate and/or buffer, selected from group, comprising histidine-aspartate, histidine-glutamate buffer, tris(hydroxymethyl)aminomethane-aspartate buffer or tris(hydroxymethyl)aminomethane-glutamate buffer, wherein the antibody concentration is 50 mg/ml or more, and the antibody is an antibody that has been modified to have an isoelectric point (pI) of 5 to 8.
EFFECT: invention allows to obtain a significant stabilization effect by using an aspartic acid or glutamic acid, as a counter ion species in histidine buffer or tris(hydroxymethyl)aminomethane, specifically by using histidine-aspartate buffer or histidine-glutamate buffer, or tris(hydroxymethyl)aminomethane-aspartate or tris(hydroxymethyl)aminomethane-glutamate as a buffer.
19 cl, 24 dwg, 8 ex, 14 tbl
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Authors
Dates
2018-05-08—Published
2011-01-20—Filed