公开(公告)号：US11918650B2

公开(公告)日：2024-03-05

申请号：US15972489

申请日：2018-05-07

申请人： AMGEN INC.

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

IPC分类号： 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分类号： 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

摘要： 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：US20240208680A1

公开(公告)日：2024-06-27

申请号：US18288549

申请日：2022-05-19

申请人： AMGEN INC.

发明人： Devrishi Goswami ,  Jun Zhang ,  Deirdre Piedmonte ,  Vikashni Padmakumar ,  David Le ,  Maria Raquel Santos ,  Wei Qi

IPC分类号： B65B3/00 ,  B65B3/12 ,  B65B3/28

CPC分类号： B65B3/003 ,  B65B3/12 ,  B65B3/28

摘要： A method of filing a vial. The method includes providing a pump corresponding to a vial and setting a drip retraction parameter for the pump to any value equal to or less than 20 degrees. The method also includes setting a no adjustment limit for a fill weight of the vial to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight T0, wherein a process performance index Cpk (Cpk) for the vial throughout a fil cycle exceeds a minimum value.

公开(公告)号：US20190151448A1

公开(公告)日：2019-05-23

申请号：US15972489

申请日：2018-05-07

申请人： AMGEN INC.

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

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

摘要： 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.