公开(公告)号：US20230035363A1

公开(公告)日：2023-02-02

申请号：US17436218

申请日：2020-03-04

Applicant: AMGEN INC.

Inventor： Dong XIANG ,  Qingchun ZHANG ,  Marisa JOUBERT ,  Trent MUNRO ,  Ronandro DE GUZMAN

IPC: G01N33/68 ,  G01N30/14 ,  G01N21/64

Abstract: Provided herein are in vitro methods of assaying an in vivo level of high molecular weight (HMW) species of a therapeutic protein. In exemplary embodiments, the method comprises (a) incubating a mixture comprising (i) a sample comprising the therapeutic protein and (ii) serum, or a depleted fraction thereof; and (b) assaying the level of HMW species of the therapeutic protein present in the mixture at one or more time points after step (a). Also methods of determining the in vivo reversibility of HMW species of a therapeutic protein are provided herein. In exemplary instances, the method comprises (A) assaying the in vivo level of high molecular weight (HMW) species of a therapeutic protein according to a presently disclosed in vitro method, and (B) comparing the level(s) of HMW species present in the mixture to the level of HMW species present in the sample prior to the incubating step.

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.

公开(公告)号：US20250147008A1

公开(公告)日：2025-05-08

申请号：US18684262

申请日：2022-08-19

Applicant: AMGEN INC.

Inventor： Marisa K. JOUBERT ,  Nathan H. JOH ,  Joshua M. TOKUDA ,  John FERBAS ,  Jiansong XIE ,  Dong XIANG

IPC: G01N33/50

Abstract: Method for investigating subcutaneous administration of a therapeutic compound product comprising providing a live in vitro mammalian skin sample comprising a dermal layer and epidermal layer, administering a therapeutic compound product to the interface between the dermal layer and the epidermal layer and analysing the skin sample.