IN VITRO PREDICTION OF ANTIBODY HALF-LIFE IN VIVO Russian patent published in 2019 - IPC B01D15/38 B01J20/32 C07K16/00 C07K16/24 

FIELD: biotechnology.

SUBSTANCE: method comprises the following steps: a) determining the retention time of the antibody and the control antibody on a FcRn-based affinity chromatography column with elution with a positive linear pH gradient in presence of 50 mM to 200 mM sodium chloride; b) determining the retention time of the antibody and the control antibody on a FcRn-based affinity chromatography column with elution with a positive linear pH gradient in presence of 300 mM to 600 mM sodium chloride. Antibody with an increased half-life in vivo relative to the control antibody is selected from an antibody which has a retention time determined at step a) which is at least 5 % greater than the retention time of the control antibody determined at step a), and retention time determined at step a), which is within 5 % of retention time determined at step b). Antibody with reduced half-life in vivo relative to the control antibody is selected from an antibody which has a retention time defined at step a) which is at least 5 % less than the retention time of the control antibody determined at step a), and retention time determined at step a), which is within 5 % of retention time determined at step b).

EFFECT: disclosed is a method of selecting an antibody with an increased or reduced half-life in vivo relative to a full-length control antibody.

21 cl, 28 tbl, 11 ex