EP1455822A4 - Compositions lyophilisees d'anticorps monoclonaux - Google Patents

Compositions lyophilisees d'anticorps monoclonaux

Info

Publication number
EP1455822A4
EP1455822A4 EP02773798A EP02773798A EP1455822A4 EP 1455822 A4 EP1455822 A4 EP 1455822A4 EP 02773798 A EP02773798 A EP 02773798A EP 02773798 A EP02773798 A EP 02773798A EP 1455822 A4 EP1455822 A4 EP 1455822A4
Authority
EP
European Patent Office
Prior art keywords
monoclonal antibody
antibody compositions
lyophilized monoclonal
lyophilized
compositions
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP02773798A
Other languages
German (de)
English (en)
Other versions
EP1455822A2 (fr
Inventor
Tracy Chen
Glen Tolman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Biotech Inc
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
Publication of EP1455822A2 publication Critical patent/EP1455822A2/fr
Publication of EP1455822A4 publication Critical patent/EP1455822A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839Immunoglobulins [IG], 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
    • C07K16/2848Immunoglobulins [IG], 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)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP02773798A 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux Withdrawn EP1455822A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US34206301P 2001-11-09 2001-11-09
US342063P 2001-11-09
PCT/US2002/033272 WO2003041637A2 (fr) 2001-11-09 2002-10-18 Compositions lyophilisees d'anticorps monoclonaux

Publications (2)

Publication Number Publication Date
EP1455822A2 EP1455822A2 (fr) 2004-09-15
EP1455822A4 true EP1455822A4 (fr) 2004-12-29

Family

ID=23340162

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02773798A Withdrawn EP1455822A4 (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
BR112013011176A2 (pt) 2010-11-05 2020-09-01 Novartis Ag métodos de tratamento de artrite reumatoide usando antagonistas de il-17
EA202090731A1 (ru) * 2017-09-15 2020-06-11 Эмджен Инк. Способ получения лиофилизированного фармацевтического состава на основе терапевтического белка

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993000807A1 (fr) * 1991-07-03 1993-01-21 Cryolife, Inc. Procede de stabilisation de biomateriaux
WO1993014191A1 (fr) * 1992-01-21 1993-07-22 Cryopharm Corporation Procede de congelation de cellules et de matieres analogues a des cellules

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0779694B2 (ja) * 1985-07-09 1995-08-30 カドラント バイオリソ−シズ リミテツド 蛋白質および同類品の保護
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
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
DE69628007T2 (de) * 1995-06-07 2003-11-27 Elan Drug Delivery Ltd., Ruddington Verfahren zur stabilen einarbeitung von substanzen in trockene geschäumte glasmatrizen und auf diese weise hergestellte zusammensetzungen
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
KR20030074693A (ko) * 2000-12-28 2003-09-19 알투스 바이올로직스 인코포레이티드 전항체 및 이의 단편의 결정과 이의 제조 및 사용 방법

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993000807A1 (fr) * 1991-07-03 1993-01-21 Cryolife, Inc. Procede de stabilisation de biomateriaux
WO1993014191A1 (fr) * 1992-01-21 1993-07-22 Cryopharm Corporation Procede de congelation de cellules et de matieres analogues a des cellules

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CARPENTER JOHN F ET AL: "Rational design of stable lyophilized protein formulations: Some practical advice", PHARMACEUTICAL RESEARCH (NEW YORK), vol. 14, no. 8, 1997, pages 969 - 975, XP002303280, ISSN: 0724-8741 *
GARZON-RODRIGUEZ W ET AL: "Use of polymer/sugar mixtures to optimize storage stability of freeze-dried recombinant human interleukin-11", ABSTRACTS OF PAPERS AMERICAN CHEMICAL SOCIETY, vol. 221, no. 1-2, April 2001 (2001-04-01), & 221ST NATIONAL MEETING OF THE AMERICAN CHEMICAL SOCIETY; SAN DIEGO, CALIFORNIA, USA; APRIL 01-05, 2001, pages BIOT 14, XP009039111, ISSN: 0065-7727 *
SEARLES JAMES A ET AL: "Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine Tg' in pharmaceutical lyophilization", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 90, no. 7, July 2001 (2001-07-01), pages 872 - 887, XP002303281, ISSN: 0022-3549 *

Also Published As

Publication number Publication date
JP2005508992A (ja) 2005-04-07
WO2003041637A3 (fr) 2004-01-22
EP1455822A2 (fr) 2004-09-15
WO2003041637A2 (fr) 2003-05-22
TW200303213A (en) 2003-09-01
CA2466641A1 (fr) 2003-05-22
AR037304A1 (es) 2004-11-03
MXPA04004459A (es) 2005-05-16

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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Effective date: 20040608

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Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR IE IT LI LU MC NL PT SE SK TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

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Effective date: 20041116

17Q First examination report despatched

Effective date: 20060927

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18D Application deemed to be withdrawn

Effective date: 20070208