Title:
LYOPHILIZED THERAPEUTIC PEPTIBODY FORMULATIONS
Document Type and Number:
Japanese Patent JP2022166219
Kind Code:
A
Abstract:
To provide long-term stable formulations of a lyophilized therapeutic peptibody, and methods for making a lyophilized composition comprising a therapeutic peptibody.SOLUTION: A lyophilized therapeutic peptibody composition comprises a buffer, a bulking agent, a stabilizing agent, and optionally a surfactant, where the therapeutic peptibody comprises a structure represented by Formula I, [(X1)a-F1-(X2)b]-(L1)c-WSPd. (In the formula, F1 is an Fc domain; X1 is P1-(L2)e-, P2-(L3)f-P1-(L2)e-, or the like; X2 is -(L2)e-P1, -(L2)e-P1-(L3)f-P2, or the like; P1 and P2 are sequences of pharmacologically active peptides; L1, L2 and L3 are linkers; a, b, c, e and f are 0 or 1; d is 0, 1, or greater than 1; and WSP is a water soluble polymer.)SELECTED DRAWING: None
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Inventors:
William J. Callahan
Litchiard El Remel Giunia
Gayatri Ratnaswami
Ramil F Lapipob
Dainjiang Liu
Litchiard El Remel Giunia
Gayatri Ratnaswami
Ramil F Lapipob
Dainjiang Liu
Application Number:
JP2022130437A
Publication Date:
November 01, 2022
Filing Date:
August 18, 2022
Export Citation:
Assignee:
Amgen K.A., Inc.
International Classes:
A61K38/10; A61K9/08; A61K9/19; A61K38/16; A61K39/395; A61K47/02; A61K47/04; A61K47/10; A61K47/12; A61K47/14; A61K47/18; A61K47/20; A61K47/22; A61K47/24; A61K47/26; A61K47/28; A61K47/32; A61K47/34; A61K47/36; A61K47/38; A61K47/40; A61K47/60; A61K47/65; A61K47/68; A61P43/00; C07K1/00; C07K7/08; C07K16/00; C07K19/00; C12P21/02
Attorney, Agent or Firm:
Kawaguchi International Patent Office
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