FORMULATIONS OF SINGLE DOMAIN ANTIGEN BINDING MOLECULES

Title:

FORMULATIONS OF SINGLE DOMAIN ANTIGEN BINDING MOLECULES

Document Type and Number:

Japanese Patent JP2015091844

Kind Code:

A

Abstract:

PROBLEM TO BE SOLVED: To provide a single domain antigen binding molecule (SDAB) for particularly subcutaneous administration to treat or prevent TNF-associated disorders and the like, which is stable for long-term storage and delivery, particularly to provide formulations of TNF-binding nanobody molecules.SOLUTION: The invention provides a formulation contains a) an SDAB molecule comprising one or more single domain molecules, wherein at least one single domain molecule binds to a human serum albumin (HSA), the concentration is about 0.1 mg/mL to about 350 mg/mL, and a single domain molecule bound to e.g., at least one, preferably two tumor necrosis factors α are comprised; (b) a freeze-dried protective agent; and (c) histidine buffer solution with a concentration of about 5 mM to about 50 mM so that the pH of a formulation is about 5.0-7.5.

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Inventors:

JASON E FERNANDEZ
DANIEL A DIXON
ANDREA PAULSON

Application Number:

JP2014262998A

Publication Date:

May 14, 2015

Filing Date:

December 25, 2014

Export Citation:

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Assignee:

ABLYNX NV

International Classes:

A61K39/395; A61K9/08; A61K47/02; A61K47/10; A61K47/18; A61K47/22; A61K47/26; A61K47/34; A61P1/00; A61P3/10; A61P5/00; A61P9/00; A61P17/00; A61P17/06; A61P19/02; A61P21/04; A61P25/00; A61P29/00; A61P31/04; A61P37/02; A61P37/06; A61P37/08

Domestic Patent References:

JP2003516361A	2003-05-13
JP2006249083A	2006-09-21
JP2006249081A	2006-09-21
JP2006249084A	2006-09-21
JPH11510170A	1999-09-07

Foreign References:

WO2006122786A2	2006-11-23
WO2007014073A2	2007-02-01

Other References:

"UNDERSTANDING NANOBODIES", アブリンクス社ホームページ, [2015/11/13検索], JPN6015046835, ISSN: 0003200104

Attorney, Agent or Firm:

Patent business corporation Tsukuni
Hajime Tsukuni
Toshio Miyake
Akio Shibata
Yasuhiro Oguni
Yoko Tanaka
Yoshinori Ikukawa

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