DEVICE AND METHODS FOR SELECTING ANTIBODIES Russian patent published in 2021 - IPC G01N33/483 A61K39/395 

FIELD: selection and preparation of antibodies.

SUBSTANCE: method of determining the suitability of an antibody solution for inclusion in a pharmaceutical composition involves establishing an upper viscosity limit; calculation proceeding from information on primary structure of structural information on antibody in solution, total charge and charge asymmetry. Primary structure includes: the amino acid sequence of the variable light chain domain (VL) and the amino acid sequence of the variable heavy chain (VH) domain; obtaining: a first scaling factor, which corresponds to common charge, of second scaling factor, which corresponds to charge asymmetry; calculation of the index based on the target function, containing scaling factors, total charge and charge asymmetry, wherein the index is the viscosity of the antibody solution; and determining that the antibody solution is suitable for inclusion in the pharmaceutical composition, taking into account the above value not exceeding the upper viscosity limit. Also disclosed is a version of a method for determining the suitability of a target antibody solution for inclusion in a pharmaceutical composition, method of selecting between a first antibody solution and a second antibody solution for inclusion in a pharmaceutical composition.

EFFECT: group of inventions provides higher probability of technical success for effective promotion of new therapeutic agents based on mAb in clinical practice.

28 cl, 19 dwg, 1 tbl