STABLE FORMULATIONS OF IMMUNOGLOBULIN SINGLE VARIABLE DOMAIN AND USE THEREOF Russian patent published in 2018 - IPC A61K39/395 A61K47/26 

FIELD: chemistry.

SUBSTANCE: group of inventions relates to medicine and relates to a composition for the treatment or prevention of disorders associated with von Willebrand Factor (vWF) that contain (a) a vWF binder comprising an immunoglobulin single variable domain, (b) sucrose, (c) Tween-80, and (d) a citrate buffer such that the pH of the composition is 6.5. Also, the group of inventions relates to a process for the preparation of said composition comprising the steps of expressing the vWF binder in a cell culture, purifying the vWF binder by conducting the vWF binder through, at least one, chromatographic cleaning step and an ultrafiltration / diafiltration step, adjusting the concentration of the vWF binder. Also, the group of inventions relates to a kit for the treatment and prevention of disorders associated with a vWF, including a container containing said composition and instructions for use.

EFFECT: group of inventions provides a high stability of the polypeptide, allowing for many freeze-thaw cycles without chemical or physical damage, and provides stability with respect to mechanical stress, such as shaking, shearing, or stirring.

12 cl, 1 ex, 11 dwg, 29 tbl