AU2014273034B2 - Antibody composition and buffer system therefor - Google Patents

Antibody composition and buffer system therefor Download PDF

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Publication number
AU2014273034B2
AU2014273034B2 AU2014273034A AU2014273034A AU2014273034B2 AU 2014273034 B2 AU2014273034 B2 AU 2014273034B2 AU 2014273034 A AU2014273034 A AU 2014273034A AU 2014273034 A AU2014273034 A AU 2014273034A AU 2014273034 B2 AU2014273034 B2 AU 2014273034B2
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Australia
Prior art keywords
buffer
antibody
acid
pka
compound
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AU2014273034A
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AU2014273034A1 (en
Inventor
Bianca Fusetti
Nicolas Steven Gee
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Abcam Ltd
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Abcam Ltd
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6843—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a material from animals or humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A61K47/6923—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0021—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
    • A61K49/0041—Xanthene dyes, used in vivo, e.g. administered to a mice, e.g. rhodamines, rose Bengal
    • A61K49/0043—Fluorescein, used in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0045—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent agent being a peptide or protein used for imaging or diagnosis in vivo
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/001—Preparation for luminescence or biological staining
    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/005—Fluorescence in vivo characterised by the carrier molecule carrying the fluorescent agent
    • A61K49/0058—Antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/13—Labelling of peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Ceramic Engineering (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
AU2014273034A 2013-05-31 2014-05-30 Antibody composition and buffer system therefor Active AU2014273034B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1309759.7A GB2516808A (en) 2013-05-31 2013-05-31 Antibody composition and buffer system therefor
GB1309759.7 2013-05-31
PCT/EP2014/061281 WO2014191560A1 (en) 2013-05-31 2014-05-30 Antibody composition and buffer system therefor

Publications (2)

Publication Number Publication Date
AU2014273034A1 AU2014273034A1 (en) 2016-01-28
AU2014273034B2 true AU2014273034B2 (en) 2019-11-21

Family

ID=48805557

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014273034A Active AU2014273034B2 (en) 2013-05-31 2014-05-30 Antibody composition and buffer system therefor

Country Status (9)

Country Link
US (1) US11046753B2 (enExample)
EP (1) EP3003385B1 (enExample)
JP (2) JP2016530216A (enExample)
CN (1) CN105592860B (enExample)
AU (1) AU2014273034B2 (enExample)
DK (1) DK3003385T3 (enExample)
ES (1) ES2762501T3 (enExample)
GB (2) GB2516808A (enExample)
WO (1) WO2014191560A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170189548A1 (en) * 2015-11-25 2017-07-06 Immunogen, Inc. Pharmaceutical formulations and methods of use thereof
KR102337683B1 (ko) * 2018-09-21 2021-12-13 주식회사 녹십자 고효율 항-tfpi 항체 조성물
CN111896752A (zh) * 2020-08-11 2020-11-06 上海捷门生物技术有限公司 一种适用于多种poct类仪器的c-反应蛋白试剂盒
CN113671188A (zh) * 2021-08-10 2021-11-19 江南大学 一种检测贝类食品中河豚毒素的时间分辨免疫定量试纸条
EP4218562A1 (en) 2022-01-28 2023-08-02 Charité - Universitätsmedizin Berlin Real-time breath antigen detection system and method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112838A1 (en) * 2005-04-18 2006-10-26 Xtl Biopharmaceuticals Ltd. Stabilized anti-hepatitis b (hbv) antibody formulations
WO2008079290A2 (en) * 2006-12-21 2008-07-03 Amgen Inc Stable buffered formulations containing polypeptides
EP1977763A1 (en) * 2005-12-28 2008-10-08 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilizing preparation
EP2380593A1 (en) * 2010-04-23 2011-10-26 Arkray, Inc. Stabilizing labeled antibody using amino acids

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0516873A1 (en) 1991-06-06 1992-12-09 THE STATE of ISRAEL Atomic Energy Commission Soreq Nuclear Research Center A method and kit for protein labelling with 99 mTC
ATE260674T1 (de) * 1998-08-17 2004-03-15 Pfizer Prod Inc Stabilisierte proteinzusammensetzung
AU2006295340B2 (en) 2005-08-05 2010-11-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
CN101330931B (zh) * 2005-12-12 2012-09-05 创新生物科学有限公司 制备缀合物
CN102089662B (zh) 2008-07-16 2015-05-27 雷迪奥米特医学公司 高容量固相
EP2583973B1 (en) 2010-06-21 2018-03-21 Kyowa Hakko Kirin Co., Ltd. Method for purifying protein using amino acid
US8877892B2 (en) * 2011-03-15 2014-11-04 Innova Biosciences Limited Conjugation reactions
EP2686334B2 (en) 2011-03-16 2020-07-01 F.Hoffmann-La Roche Ag Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
KR20120128440A (ko) 2011-05-17 2012-11-27 삼성전자주식회사 표적 물질 검출용 키트 및 이를 이용한 표적 물질 검출 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112838A1 (en) * 2005-04-18 2006-10-26 Xtl Biopharmaceuticals Ltd. Stabilized anti-hepatitis b (hbv) antibody formulations
KR20070122554A (ko) * 2005-04-18 2007-12-31 엑스티엘 바이오파마수티칼즈 엘티디. 안정화된 항-ｂ형 간염 바이러스 (ｈｂｖ) 항체 제형
EP1977763A1 (en) * 2005-12-28 2008-10-08 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilizing preparation
WO2008079290A2 (en) * 2006-12-21 2008-07-03 Amgen Inc Stable buffered formulations containing polypeptides
EP2380593A1 (en) * 2010-04-23 2011-10-26 Arkray, Inc. Stabilizing labeled antibody using amino acids

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
EJIMA, O et al. Effective elution of antibodies by arginine and arginine derivatives in affinity column chromatography. Analytical Biochemistry, 2005, vol. 345, no. 2, pages 250-257 *
ESSEN, L O et al. Single-step purification of a bacterially expressed antibody Fv fragment by immobilized metal affinity chromatography in the presence of betaine. Journal of Chromatography A, 1993, vol. 657, no. 1, 24 pages 55-61 *
FALCONER, Robert J et al. Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients. Journal of Chemical Technology & Biotechnology, 2011, vol. 86, no. 7, pages 942-948 *

Also Published As

Publication number Publication date
GB201309759D0 (en) 2013-07-17
GB201522774D0 (en) 2016-02-03
US11046753B2 (en) 2021-06-29
WO2014191560A1 (en) 2014-12-04
JP2016530216A (ja) 2016-09-29
ES2762501T8 (es) 2020-06-18
JP2020007343A (ja) 2020-01-16
US20160122416A1 (en) 2016-05-05
ES2762501T3 (es) 2020-05-25
AU2014273034A1 (en) 2016-01-28
CN105592860B (zh) 2021-02-02
GB2516808A (en) 2015-02-11
EP3003385B1 (en) 2019-09-18
GB2530217A (en) 2016-03-16
EP3003385A1 (en) 2016-04-13
DK3003385T3 (da) 2020-01-06
CN105592860A (zh) 2016-05-18

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Owner name: ABCAM PLC

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