FIELD: biotechnology; medicine.
SUBSTANCE: group of inventions refers to biotechnology and biochemistry. Methods for reducing and/or removing FXI and FXIa from a source solution containing said coagulation factors and immunoglobulins as main components are provided. Source solution is contacted with an affinity chromatographic gel, where heparin or heparan is bound to the matrix material. Provide adsorption of FXI and FXIa. Isolate the FXI and FXIa-depleted liquid from the adsorbent medium. FXI and FXIa are further eluted from the adsorption medium with a buffer containing 0.2–1.4 M NaCl or buffers of equivalent ionic strength to provide the FXI and FXIa eluates. In another embodiment of the method, at least one step of inactivating the viruses using tri-N-butyl phosphate and detergent and a concentration step to obtain an immunoglobulin-γ-containing concentrate. All steps of these methods are carried out in the absence of Polybrene® (hexadimethrin bromide) and benzamidine.
EFFECT: inventions allow to obtain an immunoglobulin solution depleted in FXI and FXIa by a single method and selectively elute FXI and FXIa from antithrombin-saturated affine gel, while both products do not contain Polybrene® and benzamidine, which are undesirable for therapeutic agents.
13 cl, 3 tbl, 2 ex
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Authors
Dates
2018-04-02—Published
2011-11-16—Filed