公开(公告)号：US20240336685A1

公开(公告)日：2024-10-10

申请号：US17281896

申请日：2019-09-27

Applicant: AMGEN INC.

Inventor： Bharadwaj Jagannathan ,  Joon Huh ,  Michael J. Treuheit ,  Daxian Shan

IPC: C07K16/28

CPC classification number: C07K16/2809 ,  C07K16/2803 ,  C07K16/2878 ,  C07K2317/10 ,  C07K2317/31

Abstract: The invention disclosed herein relates to methods for reducing aggregation of bispecific antibodies, for example reducing aggregation of bispecific T cell engager (BiTE) antibody constructs, resulting from storage under frozen conditions by holding the antibodies at certain temperatures after thaw.

公开(公告)号：US11918650B2

公开(公告)日：2024-03-05

申请号：US15972489

申请日：2018-05-07

Applicant: AMGEN INC.

Inventor： Jeff Abel ,  Lingwen Cui ,  Devrishi Goswami ,  Joon Huh ,  Bharadwaj Jagannathan ,  Sekhar Kanapuram ,  Arnold McAuley ,  Michael Schneider ,  Ananthakrishnan G. Sethuraman ,  Michael Treuheit ,  Jun Zhang

IPC: A61K39/395 ,  A61K9/00 ,  A61K9/08 ,  A61K9/19 ,  A61K47/10 ,  A61K47/12 ,  A61K47/14 ,  A61K47/18 ,  A61K47/24 ,  A61K47/26 ,  C07K16/28 ,  C07K16/46 ,  A61J1/05 ,  A61J1/10 ,  A61K39/00

CPC classification number: A61K39/39591 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K39/3955 ,  A61K47/10 ,  A61K47/12 ,  A61K47/14 ,  A61K47/183 ,  A61K47/24 ,  A61K47/26 ,  C07K16/2803 ,  C07K16/2809 ,  C07K16/2863 ,  C07K16/468 ,  A61J1/05 ,  A61J1/10 ,  A61K2039/54 ,  A61K2039/545 ,  A61K2039/627 ,  C07K2317/24 ,  C07K2317/31 ,  C07K2317/41 ,  C07K2317/569

Abstract: The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.

公开(公告)号：US20200332000A1

公开(公告)日：2020-10-22

申请号：US16482603

申请日：2018-02-02

Applicant: AMGEN RESEARCH (MUNICH) GMBH ,  AMGEN INC.

Inventor： Arnold Mcauley ,  Pavan Ghattyvenkatakrishna ,  Jeff Abel ,  Joon Huh ,  Cornelius Pompe ,  Sekhar Kanapuram ,  Michael Treuheit ,  Bharadwaj Jagannathan

IPC: C07K16/28 ,  A61K47/26

Abstract: The present disclosure provides a low pH pharmaceutical composition comprising (a) an antibody constructs comprising a first domain binding to a target cell surface antigen, a second domain binding to a second antigen and preferably a third domain, which is a specific Fc modality, (b) at least one buffer agent, (c) at least one saccharide, and (d) at least one surfactant; and wherein the pH of the pharmaceutical composition is in the range of 3.5 to 6.

公开(公告)号：US20190151448A1

公开(公告)日：2019-05-23

申请号：US15972489

申请日：2018-05-07

Applicant: AMGEN INC.

Inventor： Jeff Abel ,  Lingwen Cui ,  Devrishi Goswami ,  Joon Huh ,  Bharadwaj Jagannathan ,  Sekhar Kanapuram ,  Arnold McAuley ,  Michael Schneider ,  Ananthakrishnan G. Sethuraman ,  Michael Treuheit ,  Jun Zhang

IPC: A61K39/395 ,  C07K16/28 ,  A61K47/10 ,  A61K47/14 ,  A61K47/24 ,  A61K47/12 ,  A61K47/26 ,  A61K47/18 ,  C07K16/46

Abstract: The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.