公开(公告)号：US20240043501A1

公开(公告)日：2024-02-08

申请号：US18031691

申请日：2021-10-14

Applicant: AMGEN INC.

Inventor： Alla POLOZOVA ,  Chendi NIU ,  Ramsey A. SALEEM ,  Sreekanth SURAVAJJALA

IPC: C07K16/00 ,  C07K1/16

CPC classification number: C07K16/00 ,  C07K1/16 ,  C07K2317/14 ,  C07K2317/41 ,  C07K2317/732

Abstract: Provided herein are methods of producing an antibody composition comprising determining the relative unpaired afucosylated glycan content and/or the relative unpaired high mannose glycan content of a sample of the antibody composition and selecting the antibody composition for downstream processing based on the relative unpaired afucosylated glycan content and/or relative unpaired high mannose glycan content and/or the ADCC level of the antibody composition. Related methods of determining the relative unpaired glycan content of an antibody composition and methods of modifying the ADCC level of an antibody composition are provided herein.

公开(公告)号：US20220033511A1

公开(公告)日：2022-02-03

申请号：US17275140

申请日：2019-09-10

Applicant: Amgen Inc.

Inventor： Alla POLOZOVA ,  Qingchun ZHANG ,  Scott KUHNS ,  Dong XIANG

IPC: C07K16/28 ,  C07K16/32 ,  C07K16/24

Abstract: The present disclosure provides a method of controlling the Antibody Dependent Cellular Cytotoxicity (ADCC) activity of a glycosylated and afucosylated IgG1 antibody composition. In exemplary embodiments, the method includes (1) determining the ADCC activity of a glycosylated and afucosylated IgG1 antibody composition; and (2) increasing or decreasing the ADCC activity of the IgG1 antibody composition by increasing or decreasing the amount of terminal β-galactose in the afucosylated glycan species at the consensus glycosylation site. Related methods of matching ADCC activity of a reference glycosylated and afucosylated IgG1 antibody composition and methods of engineering a specific target ADCC activity of a glycosylated and afucosylated IgG1 antibody composition are further provided herein.