FIELD: medicine; pharmaceuticals.
SUBSTANCE: methods have been proposed for obtaining a stable pharmaceutical preparation of a single domain antigen binding molecule (SDAB) containing a lyoprotectant, a histidine buffer and a SDAB containing at least two single domain molecules, in which one single domain molecule binds to human serum albumin (HSA) and at least one other single-domain molecule binds to another human target antigen or its epitope.
EFFECT: resulting formulation, including one reconstituted after freeze-drying, is not prone to aggregation, fragmentation, deamination, oxidation, or change in its biological activity over a long period of time.
4 cl, 32 dwg, 2 tbl, 12 ex
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Authors
Dates
2019-04-02—Published
2013-02-01—Filed