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Title:
NOVEL FORMULATIONS FOR STABILIZING AND INHIBITING PRECIPITATION OF IMMUNOGENIC COMPOSITIONS
Document Type and Number:
Japanese Patent JP2018123145
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide novel formulations that inhibit precipitation of immunogenic compositions.SOLUTION: Provided is a formulation that stabilizes polysaccharide-protein conjugates such as S. Pneumoniae serotype 4 polysaccharide conjugated to CRM197 polypeptide, S. Pneumoniae serotype 6B polysaccharide conjugated to CRM197 polypeptide, S. Pneumoniae serotype 9V polysaccharide conjugated to CRM197 polypeptide, S. Pneumoniae serotype 14 polysaccharide conjugated to CRM197 polypeptide, S. Pneumoniae serotype 18C polysaccharide conjugated to CRM197 polypeptide and S. Pneumoniae serotype 19F polysaccharide conjugated to CRM197 polypeptide, the formulation comprising: (i) a pH buffer saline solution, where the buffer solution has a pKa of about 3.5 to about 7.5; (ii) a surfactant; and (iii) one or more polysaccharide-protein conjugates.SELECTED DRAWING: None

Inventors:
LAKSHMI KHANDKE
YING CHEN
HAN HANYOUNG
ROBERT CHANCEY SEID JR
ZHAOWEI JIN
JEE LOON LOOK
RONALD MALONE
XUDONG YANG
Application Number:
JP2018071339A
Publication Date:
August 09, 2018
Filing Date:
April 03, 2018
Export Citation:
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Assignee:
WYETH LLC
International Classes:
A61K35/74; A61K39/00; A61K39/09; A61K39/39; A61K47/10; A61K47/18; A61K47/24; A61K47/64; A61P31/04
Domestic Patent References:
JP2005508981A2005-04-07
JP2004511511A2004-04-15
JP2001519814A2001-10-23
JP2004502782A2004-01-29
JP2004501873A2004-01-22
JP2001525815A2001-12-11
Foreign References:
WO2004067030A22004-08-12
Other References:
新・薬剤学総論, vol. 改訂第3版, JPN6012031024, 10 April 1987 (1987-04-10), pages 34 - 36, ISSN: 0003953388
Attorney, Agent or Firm:
Noh four