WO2006125207A3 - Compositions and methods for increasing the stability of antibodies - Google Patents

Compositions and methods for increasing the stability of antibodies Download PDF

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Publication number
WO2006125207A3
WO2006125207A3 PCT/US2006/019650 US2006019650W WO2006125207A3 WO 2006125207 A3 WO2006125207 A3 WO 2006125207A3 US 2006019650 W US2006019650 W US 2006019650W WO 2006125207 A3 WO2006125207 A3 WO 2006125207A3
Authority
WO
WIPO (PCT)
Prior art keywords
compositions
methods
antibodies
stability
increasing
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.)
Ceased
Application number
PCT/US2006/019650
Other languages
French (fr)
Other versions
WO2006125207A2 (en
Inventor
Grace C Chu
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.)
Amgen Inc
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Priority to CA2607663A priority Critical patent/CA2607663C/en
Priority to AU2006247039A priority patent/AU2006247039B2/en
Priority to EP20060760250 priority patent/EP1888637A2/en
Priority to MX2007014148A priority patent/MX2007014148A/en
Priority to JP2008512584A priority patent/JP5053264B2/en
Publication of WO2006125207A2 publication Critical patent/WO2006125207A2/en
Publication of WO2006125207A3 publication Critical patent/WO2006125207A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention encompasses pharmaceutical compositions comprising an antibody and methods of formulating antibodies. The heavy and/or a light chain variable region of the antibody may have certain characteristics. In some embodiments, the antibody may comprise an N-glycan site in a heavy and/or light chain variable region. The compositions may comprise a buffering agent and, optionally, a sugar and/or a salt.
PCT/US2006/019650 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies Ceased WO2006125207A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2607663A CA2607663C (en) 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies
AU2006247039A AU2006247039B2 (en) 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies
EP20060760250 EP1888637A2 (en) 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies
MX2007014148A MX2007014148A (en) 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies.
JP2008512584A JP5053264B2 (en) 2005-05-19 2006-05-18 Compositions and methods for increasing antibody stability

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US68347505P 2005-05-19 2005-05-19
US60/683,475 2005-05-19

Publications (2)

Publication Number Publication Date
WO2006125207A2 WO2006125207A2 (en) 2006-11-23
WO2006125207A3 true WO2006125207A3 (en) 2007-02-22

Family

ID=37413622

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/019650 Ceased WO2006125207A2 (en) 2005-05-19 2006-05-18 Compositions and methods for increasing the stability of antibodies

Country Status (7)

Country Link
US (1) US8858935B2 (en)
EP (1) EP1888637A2 (en)
JP (1) JP5053264B2 (en)
AU (1) AU2006247039B2 (en)
CA (1) CA2607663C (en)
MX (1) MX2007014148A (en)
WO (1) WO2006125207A2 (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR060487A1 (en) 2006-04-21 2008-06-18 Xoma Technology Ltd PHARMACEUTICAL COMPOSITIONS OF ANTI-BODY ANTAGONISTS ANTI-CD40
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
US8481683B2 (en) * 2006-12-01 2013-07-09 Medarex, Inc. Human antibodies that bind CD22 and uses thereof
EP2136839A4 (en) * 2007-03-22 2010-04-07 Imclone Llc Stable antibody formulations
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US20090298186A1 (en) * 2008-02-29 2009-12-03 Michael Brigham-Burke Method to Assess Stability of Proteins
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
AU2010306774A1 (en) 2009-10-14 2012-05-03 Merrimack Pharmaceuticals, Inc. Bispecific binding agents targeting IGF-1R and ErbB3 signalling and uses thereof
PT2603528T (en) 2010-08-10 2016-12-01 Glycotope Gmbh Fab-glycosylated antibodies
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
WO2012068134A1 (en) * 2010-11-15 2012-05-24 Biogen Idec Inc. Enrichment and concentration of select product isoforms by overloaded bind and elute chromatography
TW201247222A (en) * 2011-04-21 2012-12-01 Daiichi Sankyo Co Ltd Antibody liquid formulation
US9587022B2 (en) 2012-12-18 2017-03-07 The Rockefeller University Glycan-modified anti-CD4 antibody with improved HIV-1 neutralizing activity
EP2934589B1 (en) * 2012-12-18 2021-01-13 The Rockefeller University Glycan-modified anti-cd4 antibodies for hiv prevention and therapy
AU2014233393B2 (en) 2013-03-15 2020-05-28 Genentech, Inc. Cell culture compositions with antioxidants and methods for polypeptide production
HUE056580T2 (en) 2013-05-30 2022-02-28 Kiniksa Pharmaceuticals Ltd Oncostatin M receptor antigen binding proteins
US10413615B2 (en) * 2014-11-19 2019-09-17 Immunogen, Inc. Process for preparing cell-binding agent-cytotoxic agent conjugates
MX2019004766A (en) * 2016-10-24 2019-09-27 Novimmune Sa METHODS, COMPOSITIONS AND DOSAGE REGIMES TO TREAT OR PREVENT INDICATIONS RELATED TO INTERFERON-GAMMA.
MX2019012255A (en) * 2017-04-11 2019-12-05 Kiniksa Pharmaceuticals Ltd Stable anti-osmr antibody formulation.
CN107490676B (en) * 2017-08-10 2019-02-12 迈克生物股份有限公司 A kind of complement C3 detection kit and detection method
CN107490675B (en) * 2017-08-10 2019-02-12 迈克生物股份有限公司 A kind of immunoturbidimetric kit and detection method
CN107490696A (en) * 2017-08-10 2017-12-19 迈克生物股份有限公司 A kind of Retinal-binding protein detection kit and detection method
SG11202010496WA (en) 2018-05-18 2020-12-30 Daiichi Sankyo Co Ltd Anti-muc1 antibody-drug conjugate

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003105894A1 (en) * 2002-06-14 2003-12-24 Medimmune, Inc. Stabilized liquid anti-rsv antibody formulations

Family Cites Families (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650772A (en) 1984-08-09 1987-03-17 Abbott Laboratories Monoclonal antibody stabilization
US4597966A (en) 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
US5237054A (en) 1987-02-20 1993-08-17 Akzo Pharma Stabilized aqueous composition containing antibodies
IL162181A (en) 1988-12-28 2006-04-10 Pdl Biopharma Inc A method of producing humanized immunoglubulin, and polynucleotides encoding the same
JP3185108B2 (en) * 1990-11-07 2001-07-09 バクスター、インターナショナル、インコーポレイテッド Erythrocyte storage solution
JPH0565233A (en) 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc Monoclonal antibody-containing lyophilized preparation
GB9122820D0 (en) 1991-10-28 1991-12-11 Wellcome Found Stabilised antibodies
US5714350A (en) 1992-03-09 1998-02-03 Protein Design Labs, Inc. Increasing antibody affinity by altering glycosylation in the immunoglobulin variable region
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
GB2288732B (en) 1994-04-13 1998-04-29 Quadrant Holdings Cambridge Pharmaceutical compositions
US5705364A (en) 1995-06-06 1998-01-06 Genentech, Inc. Mammalian cell culture process
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
GB9705810D0 (en) 1997-03-20 1997-05-07 Common Services Agency Intravenous immune globulin
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
CA2371427A1 (en) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof
WO2001047554A1 (en) 1999-12-28 2001-07-05 Chugai Seiyaku Kabushiki Kaisha Stable antibody compositions and injection preparations
JP5490972B2 (en) 2000-08-04 2014-05-14 中外製薬株式会社 Protein injection formulation
AU2002213441B2 (en) 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
EP1343518B1 (en) 2000-11-07 2009-07-22 Novartis Vaccines and Diagnostics, Inc. Stabilized interferon compositions
IL157446A0 (en) 2001-02-23 2004-03-28 Immunex Corp Immunex Corp Increased recovery of active proteins
JP5052736B2 (en) 2001-05-30 2012-10-17 中外製薬株式会社 Protein preparation
GB0113179D0 (en) 2001-05-31 2001-07-25 Novartis Ag Organic compounds
MXPA04000747A (en) 2001-07-25 2004-07-08 Protein Desing Labs Inc Stable lyophilized pharmaceutical formulation of igg antibodies.
IL161677A0 (en) 2001-11-08 2004-09-27 Protein Design Labs Stable liquid pharmaceutical formulation of igg antibodies
AU2003208811A1 (en) 2002-02-05 2003-09-02 Immunolex Therapeutics Aps A pair of antibody fv fragments stabilized by coiled­coil peptides
CN101721362B (en) 2002-02-14 2018-07-03 中外制药株式会社 Pharmaceutical solutions comprising antibody
US20040009168A1 (en) 2002-04-05 2004-01-15 Elizabet Kaisheva Multidose antibody formulation
US7425618B2 (en) 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
JP2005532395A (en) 2002-07-02 2005-10-27 スミスクライン・ビーチャム・コーポレイション New stable formulation
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
WO2004034988A2 (en) * 2002-10-16 2004-04-29 Amgen Inc. Human anti-ifn-ϝ neutralizing antibodies as selective ifn-ϝ pathway inhibitors
WO2004039337A2 (en) 2002-10-31 2004-05-13 Protein Design Labs, Inc. Stable liquid pharmaceutical formulation of antibodies that are prone to isomerization
AU2003293543A1 (en) 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
US20040208870A1 (en) 2003-01-30 2004-10-21 Medimmune, Inc. Stabilized high concentration anti-integrin alphanubeta3 antibody formulations
DK2236154T3 (en) 2003-02-10 2018-06-25 Biogen Ma Inc IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT
HUE026793T2 (en) 2003-10-01 2016-07-28 Kyowa Hakko Kirin Co Ltd Method of stabilizing antibody and stabilized solution-type antibody preparation
AU2005299716B2 (en) 2004-10-22 2012-09-06 Amgen Inc. Methods for refolding of recombinant antibodies

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003105894A1 (en) * 2002-06-14 2003-12-24 Medimmune, Inc. Stabilized liquid anti-rsv antibody formulations

Non-Patent Citations (13)

* Cited by examiner, † Cited by third party
Title
CHEN BEI ET AL: "Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms", PHARMACEUTICAL RESEARCH, NEW YORK, NY, US, vol. 20, no. 12, December 2003 (2003-12-01), pages 1952 - 1960, XP002386671, ISSN: 0724-8741 *
CHIRINO ARTHUR J ET AL: "Characterizing biological products and assessing comparability following manufacturing changes.", NATURE BIOTECHNOLOGY. NOV 2004, vol. 22, no. 11, November 2004 (2004-11-01), pages 1383 - 1391, XP002409409, ISSN: 1087-0156 *
COMPTON B J ET AL: "MICRO ISOELECTRIC POINT HETEROGENEITY OF A MURINE MONOCLONAL ANTIBODY L6 ORIGINATING FROM CELL CULTIVATION CONDITIONS", BIOTECHNOLOGY TECHNIQUES, vol. 3, no. 5, 1989, pages 349 - 354, XP009075572, ISSN: 0951-208X *
DATABASE WWW.CASSS.ORG [online] January 2005 (2005-01-01), DILLON-TM ET AL.: "9th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products - Abstract L-304-M: Rapid Reversed-Phase LC/MS Characterization of Intact Monoclonal Antibodies for Pharmaceutics", XP002409542, retrieved from HTTP://WWW.CASSS.ORG/MEETINGS/2005WCBP/PROGRAM.HTM *
GALA FRANÇOISE A ET AL: "V region carbohydrate and antibody expression.", JOURNAL OF IMMUNOLOGY (BALTIMORE, MD. : 1950) 1 MAY 2004, vol. 172, no. 9, 1 May 2004 (2004-05-01), pages 5489 - 5494, XP002409407, ISSN: 0022-1767 *
HARRIS R J ET AL: "Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies", DRUG DEVELOPMENT RESEARCH, NEW YORK, NY, US, vol. 61, no. 3, March 2004 (2004-03-01), pages 137 - 154, XP002324970, ISSN: 0272-4391 *
LEIBIGER H ET AL: "Glycosylation analysis of a polyreactive human monoclonal IgG antibody derived from a human-mouse heterohybridoma.", MOLECULAR IMMUNOLOGY. JUN 1995, vol. 32, no. 8, June 1995 (1995-06-01), pages 595 - 602, XP002409410, ISSN: 0161-5890 *
MORAN E B ET AL: "A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma.", BIOTECHNOLOGY AND BIOENGINEERING. 5 AUG 2000, vol. 69, no. 3, 5 August 2000 (2000-08-05), pages 242 - 255, XP002409406, ISSN: 0006-3592 *
RUDD P M ET AL: "Diversification of the IgG molecule by oligosaccharides.", MOLECULAR IMMUNOLOGY. DEC 1991, vol. 28, no. 12, December 1991 (1991-12-01), pages 1369 - 1378, XP002409408, ISSN: 0161-5890 *
TACHIBANA HIROFUMI ET AL: "MODIFIED ANTIGEN-BINDING OF HUMAN ANTIBODIES WITH GLYCOSYLATION VARIATIONS OF THE LIGHT CHAINS PRODUCED IN SUGAR-LIMITED HUMAN HYBRIDOMA CULTURES", IN VITRO CELLULAR & DEVELOPMENTAL BIOLOGY. ANIMAL, TISSUE CULTURE ASSOCIATION, COLUMBIA, MD, US, vol. 32, no. 3, March 1996 (1996-03-01), pages 178 - 183, XP009073605, ISSN: 1071-2690 *
WAN H Z ET AL: "Rapid method for monitoring galactosylation levels during recombinant antibody production by electrospray mass spectrometry with selective-ion monitoring", JOURNAL OF CHROMATOGRAPHY, ELSEVIER SCIENCE PUBLISHERS B.V. AMSTERDAM, NL, vol. 913, no. 1-2, 13 April 2001 (2001-04-13), pages 437 - 446, XP004232810, ISSN: 0021-9673 *
WANG WEI: "Instability, stabilization, and formulation of liquid protein pharmaceuticals", INTERNATIONAL JOURNAL OF PHARMACEUTICS, AMSTERDAM, NL, vol. 185, no. 2, 20 August 1999 (1999-08-20), pages 129 - 188, XP002323952, ISSN: 0378-5173 *
WRIGHT A: "ANTIBODY VARIABLE REGION GLYCOSYLATION: POSITION EFFECTS ON ANTIGEN BINDING AND CARBOHYDRATE STRUCTURE", EMBO JOURNAL, OXFORD UNIVERSITY PRESS, SURREY, GB, vol. 10, no. 10, 1 October 1991 (1991-10-01), pages 2717 - 2723, XP000219694, ISSN: 0261-4189 *

Also Published As

Publication number Publication date
US8858935B2 (en) 2014-10-14
AU2006247039A1 (en) 2006-11-23
WO2006125207A2 (en) 2006-11-23
US20060269543A1 (en) 2006-11-30
CA2607663A1 (en) 2006-11-23
CA2607663C (en) 2014-08-12
AU2006247039B2 (en) 2011-03-03
JP5053264B2 (en) 2012-10-17
JP2008540684A (en) 2008-11-20
MX2007014148A (en) 2008-01-11
EP1888637A2 (en) 2008-02-20

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