STABLE COMPOSITIONS OF IMMUNOGLOBULIN SINGLE VARIABLE DOMAIN AND THEIR USE Russian patent published in 2022 - IPC A61K39/395 A61K9/08 A61K9/19 A61P7/02 A61P7/04 A61P9/10 C07K16/36 

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine; it is intended for the treatment or prevention of Willebrand factor (hereinafter – WF)-related diseases. A composition for the treatment or prevention of WF-related diseases contains a Willebrand factor (WF)-binding agent, which contains at least one of SEQ ID NO: 1-19, citrate buffer, auxiliary substance and Twin-80. A method for the preparation of this composition includes stages of: expression of the WF-binding agent in a cell culture; purification of the WF-binding agent by chromatographic purification and ultrafiltration/diafiltration; as well as bringing to the required concentration of the WF-binding agent in the composition. In addition, this group of inventions relates to a method for the preparation of a restored composition; and a kit for the treatment or prevention of WF-related diseases.

EFFECT: implementation of the invention provides compositions that are stable during storage for long periods of time and over a wide temperature range; compositions of the present invention provide high stability of polypeptide, allowing for multiple freeze-thaw cycles without chemical or physical damage, and provide stability against mechanical stress, such as stress during shaking, shifting or mixing.

13 cl, 32 tbl, 11 dwg