CA2668947C - Liquid anti-rabies antibody formulations - Google Patents

Liquid anti-rabies antibody formulations Download PDF

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Publication number
CA2668947C
CA2668947C CA2668947A CA2668947A CA2668947C CA 2668947 C CA2668947 C CA 2668947C CA 2668947 A CA2668947 A CA 2668947A CA 2668947 A CA2668947 A CA 2668947A CA 2668947 C CA2668947 C CA 2668947C
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CA
Canada
Prior art keywords
formulation
antibody
polysorbate
antibodies
formulations
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.)
Active
Application number
CA2668947A
Other languages
English (en)
French (fr)
Other versions
CA2668947A1 (en
Inventor
Alexander Berthold Hendrik Bakker
Willem Egbert Marissen
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 Vaccines and Prevention BV
Original Assignee
Crucell Holand BV
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 Crucell Holand BV filed Critical Crucell Holand BV
Publication of CA2668947A1 publication Critical patent/CA2668947A1/en
Application granted granted Critical
Publication of CA2668947C publication Critical patent/CA2668947C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Virology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CA2668947A 2006-12-05 2007-12-04 Liquid anti-rabies antibody formulations Active CA2668947C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US87289206P 2006-12-05 2006-12-05
EP06125400 2006-12-05
US60/872,892 2006-12-05
EP06125400.9 2006-12-05
PCT/EP2007/063244 WO2008068246A1 (en) 2006-12-05 2007-12-04 Liquid anti-rabies antibody formulations

Publications (2)

Publication Number Publication Date
CA2668947A1 CA2668947A1 (en) 2008-06-12
CA2668947C true CA2668947C (en) 2017-02-07

Family

ID=39092188

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2668947A Active CA2668947C (en) 2006-12-05 2007-12-04 Liquid anti-rabies antibody formulations

Country Status (13)

Country Link
US (1) US7959922B2 (enExample)
EP (1) EP2088997B1 (enExample)
JP (1) JP5410985B2 (enExample)
KR (1) KR101522036B1 (enExample)
CN (1) CN101557799B (enExample)
AU (1) AU2007328960B2 (enExample)
CA (1) CA2668947C (enExample)
CU (1) CU23795A3 (enExample)
EA (1) EA017549B1 (enExample)
IL (1) IL199004A (enExample)
MX (1) MX2009005414A (enExample)
WO (1) WO2008068246A1 (enExample)
ZA (1) ZA200902772B (enExample)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1636265A2 (en) 2003-06-25 2006-03-22 Crucell Holland B.V. Binding molecules for the treatment of myeloid cell malignancies
ES2426725T3 (es) 2004-05-27 2013-10-24 Crucell Holland B.V. Método para identificar moléculas de unión que pueden neutralizar el virus de la rabia
EA031202B1 (ru) 2006-06-06 2018-11-30 Янссен Вэксинс Энд Превеншн Б.В. Антитело человека, обладающее фагоцитарной активностью против стафилококков, и его применение
JP5410985B2 (ja) 2006-12-05 2014-02-05 クルセル ホランド ベー ヴェー 液体抗狂犬病抗体製剤
JP2010085126A (ja) * 2008-09-29 2010-04-15 Adtec Kk 狂犬病ウイルス中和抗体価判定具および狂犬病ウイルス中和抗体価の測定方法
US8821879B2 (en) 2009-09-04 2014-09-02 Xoma Technology Ltd. Anti-botulism antibody coformulations
SG10201604104PA (en) 2011-10-25 2016-07-28 Prothena Therapeutics Ltd Antibody formulations and methods
SI2822590T1 (sl) * 2012-03-07 2017-01-31 Eli Lilly And Company Formulacije s protitelesi proti IL-17
KR20140119396A (ko) 2013-03-29 2014-10-10 삼성전자주식회사 단백질 약물의 액상 제형
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
WO2018204374A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
JP7159642B2 (ja) * 2018-06-26 2022-10-25 東ソー株式会社 カラムの抗体に対する保持力の測定方法
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
TWI878554B (zh) 2020-06-12 2025-04-01 大陸商南京維立志博生物科技股份有限公司 結合tnfr2的抗體及其用途
CN114748618B (zh) * 2022-04-02 2024-07-19 重庆智翔金泰生物制药股份有限公司 包含针对狂犬病病毒g蛋白的双特异性抗体的药物制剂及其制备方法
CN117771365B (zh) * 2023-12-07 2025-07-04 兰州生物制品研究所有限责任公司 一种抗狂犬病病毒组合单克隆抗体制剂

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0402029B1 (en) 1989-06-08 1994-01-12 The Wistar Institute Monoclonal antibodies for post exposure treatment of rabies
DE4006630A1 (de) 1990-03-03 1991-09-12 Behringwerke Ag Humane monoklonale antikoerper gegen tollwutviren, ihre herstellung und verwendung
DK0934526T3 (da) 1996-10-08 2003-05-05 Bisys B V U Fremgangsmåder og midler til udvælgelse af peptider og proteiner, der har specifik affinitet til et mål
US20040013672A1 (en) 2000-05-16 2004-01-22 Thomas Jefferson University Recombinant antibodies, and compositions and methods for making and using the same
CA2457362C (en) 2001-08-21 2012-01-17 Thomas Jefferson University Human monoclonal rabies virus neutralizing antibodies, and methods for making and using the same
AU2003250074B2 (en) 2002-07-18 2010-09-09 Merus N.V. Recombinant production of mixtures of antibodies
CA2537371A1 (en) 2003-09-04 2005-03-17 Crucell Holland B.V. Antigenic peptides of rabies virus and uses thereof
US7803914B2 (en) * 2003-10-09 2010-09-28 Chugai Seiyaku Kabushiki Kaisha Methods for stabilizing protein solutions
US20070212346A1 (en) * 2003-10-09 2007-09-13 Tomoyuki Igawa Highly Concentrated Stabilized Igm Solution
US20070184050A1 (en) * 2003-12-25 2007-08-09 Kirin Beer Kabushiki Kaisha Stable water-based medicinal preparation containing antibody
ES2426725T3 (es) 2004-05-27 2013-10-24 Crucell Holland B.V. Método para identificar moléculas de unión que pueden neutralizar el virus de la rabia
CN101166763B (zh) * 2005-04-18 2012-09-19 伊达研究和发展有限公司 稳定的抗乙肝病毒(hbv)抗体配制剂
JP5410985B2 (ja) 2006-12-05 2014-02-05 クルセル ホランド ベー ヴェー 液体抗狂犬病抗体製剤

Also Published As

Publication number Publication date
ZA200902772B (en) 2012-09-26
EA200970533A1 (ru) 2009-10-30
IL199004A0 (en) 2010-02-17
KR101522036B1 (ko) 2015-05-20
CN101557799B (zh) 2012-08-22
WO2008068246A1 (en) 2008-06-12
KR20090089881A (ko) 2009-08-24
EP2088997A1 (en) 2009-08-19
US20100034829A1 (en) 2010-02-11
AU2007328960A1 (en) 2008-06-12
MX2009005414A (es) 2009-06-01
JP2010511665A (ja) 2010-04-15
JP5410985B2 (ja) 2014-02-05
EP2088997B1 (en) 2016-08-24
EA017549B1 (ru) 2013-01-30
CN101557799A (zh) 2009-10-14
CA2668947A1 (en) 2008-06-12
CU23795A3 (es) 2012-03-15
AU2007328960B2 (en) 2013-01-17
IL199004A (en) 2015-10-29
US7959922B2 (en) 2011-06-14

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