WO2003041637A3 - Compositions lyophilisees d'anticorps monoclonaux - Google Patents

Compositions lyophilisees d'anticorps monoclonaux Download PDF

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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
English (en)
Other versions
WO2003041637A2 (fr
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 EP02773798A priority Critical patent/EP1455822A4/fr
Priority to CA002466641A priority patent/CA2466641A1/fr
Priority to MXPA04004459A priority patent/MXPA04004459A/es
Priority to JP2003543524A priority patent/JP2005508992A/ja
Publication of WO2003041637A2 publication Critical patent/WO2003041637A2/fr
Publication of WO2003041637A3 publication Critical patent/WO2003041637A3/fr

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

Abstract

L'invention concerne une composition pharmaceutique solide améliorée comprenant une composition lyophilisée d'anticorps monoclonaux qui manifeste une meilleure stabilité sous forme séchée et a une température de transition vitreuse élevée. Selon l'invention, une composition lyophilisée d'anticorps monoclonaux comprend un anticorps monoclonal thérapeutiquement actif ou un fragment de celui-ci, mélangé à un excipient stabilisateur comprenant une combinaison de disaccharide et d'amidon hydroxyéthylique. De préférence, l'anticorps monoclonal est l'abciximab.
PCT/US2002/033272 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux WO2003041637A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP02773798A EP1455822A4 (fr) 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux
CA002466641A CA2466641A1 (fr) 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux
MXPA04004459A MXPA04004459A (es) 2001-11-09 2002-10-18 Composiciones liofilizadas de anticuerpo monoclonal.
JP2003543524A JP2005508992A (ja) 2001-11-09 2002-10-18 凍結乾燥されたモノクローナル抗体組成物

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 (fr) 2003-05-22
WO2003041637A3 true WO2003041637A3 (fr) 2004-01-22

Family

ID=23340162

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/033272 WO2003041637A2 (fr) 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux

Country Status (7)

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

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
JP2012511531A (ja) * 2008-12-09 2012-05-24 エフ．ホフマン−ラ ロシュ アーゲー 賦形剤不含抗体溶液を得るための方法
WO2012028683A1 (fr) 2010-09-02 2012-03-08 Novartis Ag Système de gel d'anticorps pour administration de médicament prolongée
EP4116325A1 (fr) 2010-11-05 2023-01-11 Novartis AG Procédés de traitement de la polyarthrite rhumatoïde au moyen d'antagonistes d'il-17
MA50239A (fr) 2017-09-15 2020-07-22 Amgen Inc Procédé de formulation pharmaceutique lyophilisée d'une protéine thérapeutique

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 (fr) * 1995-06-07 1996-12-19 Quadrant Holdings Cambridge Limited Procedes permettant d'incorporer de façon stable des substances dans des matrices seches de verre mousse, et compositions ainsi obtenues
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
WO1993014191A1 (fr) * 1992-01-21 1993-07-22 Cryopharm Corporation Procede de congelation de cellules et de matieres analogues a des cellules

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 (fr) * 1995-06-07 1996-12-19 Quadrant Holdings Cambridge Limited Procedes permettant d'incorporer de façon stable des substances dans des matrices seches de verre mousse, et compositions ainsi obtenues
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
JP2005508992A (ja) 2005-04-07
EP1455822A4 (fr) 2004-12-29
TW200303213A (en) 2003-09-01
MXPA04004459A (es) 2005-05-16
CA2466641A1 (fr) 2003-05-22
AR037304A1 (es) 2004-11-03
EP1455822A2 (fr) 2004-09-15
WO2003041637A2 (fr) 2003-05-22

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