Title:
HIGH-CONCENTRATION ANTIBODY-CONTAINING SOLUTION FORMULATION
Document Type and Number:
Japanese Patent JP2018076334
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide a high concentration antibody-containing formulation that is stable and suitable for subcutaneous administration, and in which creation of dimer or deamidation is suppressed during long-term storage.SOLUTION: An antibody-containing solution formulation contains arginine (50 to 1500 mM, preferably 100 to 300 mM) and methionine (10 to 200 mM, preferably 10 to 50 mM), may contain histidine and/or tryptophan as an additional component, in which antibody concentration is 50 mg/ml or more preferably 100 mg/ml or more, more preferably 120 mg/ml or more, pH is 4 to 8, viscosity is 2 to 15 mPa s, which is produced without including a freeze-drying process, and an antibody is an interleukin-6 receptor antibody.SELECTED DRAWING: None
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Inventors:
MORICHIKA TOSHIYUKI
KAMEOKA DAISUKE
IMAEDA YOSHIMI
MAEDA TERUTOSHI
STAUCH OLIVER BORIS
KAMEOKA DAISUKE
IMAEDA YOSHIMI
MAEDA TERUTOSHI
STAUCH OLIVER BORIS
Application Number:
JP2017234971A
Publication Date:
May 17, 2018
Filing Date:
December 07, 2017
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD
HOFFMANN LA ROCHE
HOFFMANN LA ROCHE
International Classes:
A61K39/395; A61K9/08; A61K47/18; A61K47/26
Domestic Patent References:
| JP2007524602A | 2007-08-30 |
Foreign References:
| WO2007074880A1 | 2007-07-05 |
Attorney, Agent or Firm:
Shinjiro Ono
Osamu Yamamoto
Toru Miyamae
Motoharu Nakanishi
Akiko Nakahama
Osamu Yamamoto
Toru Miyamae
Motoharu Nakanishi
Akiko Nakahama