Title:
LIQUID FORMULATION CONTAINING HIGH CONCENTRATION OF ANTIBODIES
Document Type and Number:
WIPO Patent Application WO/2017/057644
Kind Code:
A1
Abstract:
The present invention can provide, at a low cost, a liquid formulation containing a high concentration of recombinant monoclonal antibodies comprising 150 mg/mL to 200 mg/mL of recombinant monoclonal antibodies, and 45 mM to 94 mM of an amino acid component in which the histidine component is less than 5 mM, and having a pH of 5.5 to 6.7. The liquid formulation containing a high concentration of recombinant monoclonal antibodies is stable, achieving limited dimer generation and limited deamidation during long-term storage, and exhibits a kinematic viscosity that allows for subcutaneous injection.
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Inventors:
OKUWAKI RYO (JP)
Application Number:
PCT/JP2016/078942
Publication Date:
April 06, 2017
Filing Date:
September 29, 2016
Export Citation:
Assignee:
MOCHIDA PHARM CO LTD (JP)
International Classes:
A61K39/395; A61K9/08; A61K47/18; A61K47/20; A61P19/02; A61P29/00; A61P37/06
Domestic Patent References:
| WO2009084659A1 | 2009-07-09 | |||
| WO2013012022A1 | 2013-01-24 |
Foreign References:
| JP2013521296A | 2013-06-10 | |||
| JP2015528465A | 2015-09-28 | |||
| JP2012533548A | 2012-12-27 | |||
| JP2013527176A | 2013-06-27 |
Other References:
SHUJINGWANG ET AL.: "Viscosity-lowering effect of amino acids and salts on highly concentrated solutions of two IgG1 monoclonal antibodies.", MOL PHARMACEUTICS., vol. 12, 3 November 2015 (2015-11-03), pages 4478 - 4487, XP055385371
Attorney, Agent or Firm:
WATANABE Mochitoshi et al. (JP)
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