公开(公告)号：US20240316194A1

公开(公告)日：2024-09-26

申请号：US18574161

申请日：2022-06-29

Applicant: AMGEN INC.

Inventor： Wei Qi ,  Cindy Ren

IPC: A61K39/395 ,  A61K9/00 ,  A61K9/19 ,  A61K39/00 ,  A61K47/10 ,  A61K47/18 ,  A61K47/26 ,  C07K16/28 ,  C07K16/30

CPC classification number: A61K39/39591 ,  A61K9/0019 ,  A61K9/19 ,  A61K47/10 ,  A61K47/183 ,  A61K47/26 ,  C07K16/2809 ,  C07K16/3092 ,  A61K2039/505 ,  C07K2317/31 ,  C07K2317/94

Abstract: Described herein is a method comprising (a) reconstituting a lyophilized formulation comprising a polypeptide, a saccharide, a surfactant, and a buffer, with a diluent comprising an aromatic alcohol, a phenolic compound, or an amino acid with aromatic side chain, and (b) administering the reconstituted formulation to a subject in need thereof within 12 hours of reconstitution, wherein the polypeptide is a bispecific antibody construct, such as a bispecific antibody construct that binds human DLL3 and human CD3 and optionally comprises the amino acid sequence of SEQ ID NO: 75 and SEQ ID NO: 9.

公开(公告)号：US20240208680A1

公开(公告)日：2024-06-27

申请号：US18288549

申请日：2022-05-19

Applicant: AMGEN INC.

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

IPC: B65B3/00 ,  B65B3/12 ,  B65B3/28

CPC classification number: B65B3/003 ,  B65B3/12 ,  B65B3/28

Abstract: 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：US20220362104A1

公开(公告)日：2022-11-17

申请号：US17770355

申请日：2020-10-23

Applicant: AMGEN INC. ,  AMGEN RESEARCH MUNICH GMBH

Inventor： Cornelius Pompe ,  Nicholas J. Clark ,  Wei Qi ,  Arnold J. McAuley ,  MIchael Schneider ,  Chia-Jung Wu ,  Twinkle R. Christian ,  Heather N. Franey ,  Bharadwaj Jagannathan ,  Jeffrey Abel ,  Franz Dietzel

IPC: A61J1/14 ,  A61M5/14 ,  G01N33/15

Abstract: An approach for determining material compatibility for components of a drug delivery system is provided that includes using surface zeta-potential analytical method to evaluate surface interactions between a desired molecule and at least one material present within a given IV-bag system.