Separation of bispecific antibodies and bispecific antibody production side products using hydroxyapatite chromatography
US10316059B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Feb 19, 2016 |
| Grant date | Jun 11, 2019 |
| Priority date | — |
| Expiry date | Dec 17, 2036 |
Classification
- Technology area (CPC C)Chemistry; Metallurgy
- CPC primaryC07K2317/66
- WIPO fieldChemical engineering
- WIPO sectorChemistry
Abstract
The present invention is directed to methods comprising the use of hydroxyapatite chromatography to separate a bispecific antibody from a solution that also comprises one or more byproducts specific to bispecific antibody production. Byproducts specific to the production of bispecific antibodies (bispecific antibody specific byproducts, “BASB”) include fragments of the bispecific antibody and heavier molecular weight variants of the antibody, wherein the fragment and/or variant comprises an Fc domain but does not exhibit affinity for the two different epitopes and/or antigens as exhibited by the desired bispecific antibody. Thus, the methods of the present invention comprise the separation of a bispecific antibody from one or more of its BASB. The hydroxyapatite chromatography methods of the invention may be used alone or may be further combined with standard purification processes and unit operations as is known in the art to achieve any level of purity of bispecific antibody necessary, e.g., for therapeutic and/or diagnostic applications.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.