ANTIBODIES FOR BINDING OF IMIGLUCERASE AND USE THEREOF IN AFFINITY CHROMATOGRAPHY Russian patent published in 2019 - IPC C07K16/40 C07K1/22 C12N9/24 

FIELD: biotechnology.

SUBSTANCE: group of inventions relates to biotechnology. Antibody or antigen binding fragment thereof for binding imiglucerase and an immunoaffinity chromatographic purification method of imiglucerase is provided. Antibody or its antigen-binding fragment comprises a combination of variable fragments of the heavy chain CDRH1, CDRH2, CDRH3 and light chain variable fragments CDRL1, CDRL2, CDRL3, corresponding to one of the following combinations: (i) SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6; (ii) SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12; (iii) SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18; (iv) SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24; (v) SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 27, SEQ ID NO: 28, SEQ ID NO: 29, SEQ ID NO: 30; (vi) SEQ ID NO: 31, SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34, SEQ ID NO: 35, SEQ ID NO: 36; (vii) SEQ ID NO: 37, SEQ ID NO: 38, SEQ ID NO: 39, SEQ ID NO: 40, SEQ ID NO: 41, SEQ ID NO: 42. Method of immunoaffinity chromatographic purification of imiglucerase involves applying to a chromatographic column with a carrier with immobilized antibodies and/or their antigen-binding fragments of the sample, containing imiglucerase, washing the column with buffer, elution of the adsorbed imiglucerase from the carrier in the presence of from 30 to 60 % ethylene glycol.

EFFECT: invention allows to obtain the preparation of active imiglucerase from the culture fluid in a single stage, which does not contain contaminants detected by polyacrylamide gel electrophoresis.

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