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WO2003041637A3 - Lyophilized monoclonal antibody compositions - Google Patents

Lyophilized monoclonal antibody compositions Download PDF

Info

Publication number
WO2003041637A3
WO2003041637A3 PCT/US2002/033272 US0233272W WO03041637A3 WO 2003041637 A3 WO2003041637 A3 WO 2003041637A3 US 0233272 W US0233272 W US 0233272W WO 03041637 A3 WO03041637 A3 WO 03041637A3
Authority
WO
WIPO (PCT)
Prior art keywords
monoclonal antibody
lyophilized
antibody compositions
lyophilized monoclonal
composition
Prior art date
Application number
PCT/US2002/033272
Other languages
French (fr)
Other versions
WO2003041637A2 (en
Inventor
Tracy Chen
Glen Tolman
Original Assignee
Centocor Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Centocor Inc filed Critical Centocor Inc
Priority to CA002466641A priority Critical patent/CA2466641A1/en
Priority to MXPA04004459A priority patent/MXPA04004459A/en
Priority to EP02773798A priority patent/EP1455822A4/en
Priority to JP2003543524A priority patent/JP2005508992A/en
Publication of WO2003041637A2 publication Critical patent/WO2003041637A2/en
Publication of WO2003041637A3 publication Critical patent/WO2003041637A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2848—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta3-subunit-containing molecules, e.g. CD41, CD51, CD61

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

The invention concerns an improved solid pharmaceutical composition comprising a lyophilized monoclonal antibody composition that exhibits enhanced stability in the dry form and a high glass transition temperature. In accordance with the invention, a lyophilized monoclonal antibody composition is provided comprising a therapeutically active monoclonal antibody or fragment thereof in admexture with a stabilizing excipient comprised of a combination of a disaccharide and a hydroxyethyl starch. Preferably, the monoclonal antibody is abciximab.
PCT/US2002/033272 2001-11-09 2002-10-18 Lyophilized monoclonal antibody compositions WO2003041637A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002466641A CA2466641A1 (en) 2001-11-09 2002-10-18 Lyophilized monoclonal antibody compositions
MXPA04004459A MXPA04004459A (en) 2001-11-09 2002-10-18 Lyophilized monoclonal antibody compositions.
EP02773798A EP1455822A4 (en) 2001-11-09 2002-10-18 Lyophilized monoclonal antibody compositions
JP2003543524A JP2005508992A (en) 2001-11-09 2002-10-18 Lyophilized monoclonal antibody composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US34206301P 2001-11-09 2001-11-09
US60/342,063 2001-11-09

Publications (2)

Publication Number Publication Date
WO2003041637A2 WO2003041637A2 (en) 2003-05-22
WO2003041637A3 true WO2003041637A3 (en) 2004-01-22

Family

ID=23340162

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/033272 WO2003041637A2 (en) 2001-11-09 2002-10-18 Lyophilized monoclonal antibody compositions

Country Status (7)

Country Link
EP (1) EP1455822A4 (en)
JP (1) JP2005508992A (en)
AR (1) AR037304A1 (en)
CA (1) CA2466641A1 (en)
MX (1) MXPA04004459A (en)
TW (1) TW200303213A (en)
WO (1) WO2003041637A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6982080B2 (en) * 2002-03-15 2006-01-03 Wyeth Hydroxyethyl starch—containing polypeptide compositions
WO2010066634A1 (en) * 2008-12-09 2010-06-17 F. Hoffmann-La Roche Ag Method for obtaining an excipient-free antibody solution
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
EP4116325A1 (en) 2010-11-05 2023-01-11 Novartis AG Methods of treating rheumatoid arthritis using il-17 antagonists
PT3681483T (en) 2017-09-15 2022-08-22 Amgen Inc Process for lyophilized pharmaceutical formulation of a therapeutic protein

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4891319A (en) * 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
WO1996040077A2 (en) * 1995-06-07 1996-12-19 Quadrant Holdings Cambridge Limited Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby
US5656272A (en) * 1991-03-18 1997-08-12 New York University Medical Center Methods of treating TNF-α-mediated Crohn's disease using chimeric anti-TNF antibodies
US5762961A (en) * 1996-02-09 1998-06-09 Quadrant Holdings Cambridge Ltd. Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof
US5955448A (en) * 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
US20020136719A1 (en) * 2000-12-28 2002-09-26 Bhami Shenoy Crystals of whole antibodies and fragments thereof and methods for making and using them

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2309692A (en) * 1991-07-03 1993-02-11 Cryolife, Inc. Method for stabilization of biomaterials
IL104470A0 (en) * 1992-01-21 1993-05-13 Cryopharm Corp Process for freezing cells and cell like materials and compositions prepared thereby

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4891319A (en) * 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
US5656272A (en) * 1991-03-18 1997-08-12 New York University Medical Center Methods of treating TNF-α-mediated Crohn's disease using chimeric anti-TNF antibodies
US6313102B1 (en) * 1994-04-13 2001-11-06 Quardrant Holdings Cambridge, Ltd. Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
US5955448A (en) * 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
WO1996040077A2 (en) * 1995-06-07 1996-12-19 Quadrant Holdings Cambridge Limited Methods for stably incorporating substances within dry, foamed glass matrices and compositions obtained thereby
US5762961A (en) * 1996-02-09 1998-06-09 Quadrant Holdings Cambridge Ltd. Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof
US20020136719A1 (en) * 2000-12-28 2002-09-26 Bhami Shenoy Crystals of whole antibodies and fragments thereof and methods for making and using them

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1455822A4 *

Also Published As

Publication number Publication date
TW200303213A (en) 2003-09-01
JP2005508992A (en) 2005-04-07
MXPA04004459A (en) 2005-05-16
WO2003041637A2 (en) 2003-05-22
AR037304A1 (en) 2004-11-03
CA2466641A1 (en) 2003-05-22
EP1455822A4 (en) 2004-12-29
EP1455822A2 (en) 2004-09-15

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