公开(公告)号：US11098079B2

公开(公告)日：2021-08-24

申请号：US15751231

申请日：2016-08-12

Applicant: AMGEN INC.

Inventor： Hai Hoang ,  Rafael Gonzalez ,  Junfen Ma

IPC: C07K1/36 ,  C07K1/18 ,  C07K1/113 ,  C07K1/34 ,  B01D15/36 ,  B01D15/38 ,  C07K1/22 ,  C07K16/28 ,  G01N27/447

Abstract: Methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced antigen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced antigen-binding protein molecules. Formulations comprising a re-oxidized antigen-binding protein are also described.

公开(公告)号：US20210363180A1

公开(公告)日：2021-11-25

申请号：US17386692

申请日：2021-07-28

Applicant: AMGEN INC.

Inventor： Hai Hoang ,  Rafael Gonzalez ,  Junfen Ma

IPC: C07K1/36 ,  C07K1/113 ,  C07K1/34 ,  B01D15/36 ,  B01D15/38 ,  C07K1/18 ,  C07K1/22 ,  C07K16/28

Abstract: Methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced anti-gen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced an¬tigen-binding protein molecules. Formulations comprising a re-oxidized antigen-binding protein are also described.

公开(公告)号：US20180230180A1

公开(公告)日：2018-08-16

申请号：US15751231

申请日：2016-08-12

Applicant: AMGEN INC.

Inventor： Hai Hoang ,  Rafael Gonzalez ,  Junfen Ma

IPC: C07K1/36 ,  C07K1/34 ,  C07K1/22 ,  C07K1/113 ,  C07K1/18 ,  C07K16/28 ,  B01D15/38 ,  B01D15/36

CPC classification number: C07K1/36 ,  B01D15/362 ,  B01D15/3809 ,  C07K1/1133 ,  C07K1/18 ,  C07K1/22 ,  C07K1/34 ,  C07K16/2887 ,  C07K2317/40 ,  G01N27/44791

Abstract: Methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced antigen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced antigen-binding protein molecules. Formulations comprising a re-oxidized antigen-binding protein are also described.