SEPARATION OF BISPECIFIC ANTIBODIES AND BY-PRODUCTS OF THE PROCESS OF OBTAINING BISPECIFIC ANTIBODIES USING HYDROXYAPATITE CHROMATOGRAPHY

摘要

FIELD: biotechnology.;SUBSTANCE: this invention relates to methods, including the use of hydroxyapatite chromatography to isolate the bispecific antibody from the solution, which also contains one or more by-products, specific for the production of bispecific antibodies. By-products, specific for the production of bispecific antibodies (bispecific antibody specific byproducts — BASB), include fragments of a bispecific antibody and variants of an antibody of higher molecular weight, wherein said fragment and/or variant comprises an Fc domain, but does not show affinity for two different epitopes and/or antigens, to which the desired bispecific antibody exhibits affinity. Thus, methods of this invention include the separation of a bispecific antibody from one or more of its BASB.;EFFECT: hydroxyapatite chromatographic methods of the invention can be used individually or can also be combined with standard cleaning processes and process operations known in the art, to achieve any level of purity of the bispecific antibody, for example, for therapeutic and/or diagnostic applications.;12 cl, 19 dwg, 6 e