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
Authority
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

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (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 (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005000894A2 (en) 2003-06-25 2005-01-06 Crucell Holland B.V. Binding molecules for the treatment of myeloid cell malignancies
WO2005118644A2 (en) * 2004-05-27 2005-12-15 Crucell Holland B.V. Binding molecules capable of neutralizing rabies virus and uses thereof
CN103351435B (zh) 2006-06-06 2015-08-19 克鲁塞尔荷兰公司 具有杀灭葡萄球菌活性的人结合分子及其应用
MX2009005414A (es) 2006-12-05 2009-06-01 Crucell Holland Bv Formulaciones liquidas de anticuerpo antirrabico.
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
CA2853112C (en) 2011-10-25 2018-08-21 Onclave Therapeutics Limited Antibody formulations and methods
MX362191B (es) * 2012-03-07 2019-01-08 Lilly Co Eli Formulacion de anticuerpo il-17.
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
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
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
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
CN113056482A (zh) 2018-10-18 2021-06-29 默沙东公司 抗rsv抗体的制剂及其使用方法
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
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
CN119405798A (zh) * 2022-04-02 2025-02-11 重庆智翔金泰生物制药股份有限公司 一种治疗狂犬病的抗体药物组合物及其制备方法
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
ES2062364T3 (es) 1989-06-08 1994-12-16 Wistar Inst Un metodo de preparacion de una composicion para el tratamiento despues de la exposicion de infeccion de rabia.
DE4006630A1 (de) 1990-03-03 1991-09-12 Behringwerke Ag Humane monoklonale antikoerper gegen tollwutviren, ihre herstellung und verwendung
JP2001512560A (ja) 1996-10-08 2001-08-21 ユー―ビスイス ベスローテン フェンノートシャップ 標的に対し特異的な親和性を有するペプチドおよびタンパク質の選択のための方法および手段
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
EP2314629B2 (en) 2002-07-18 2022-11-16 Merus N.V. Recombinant production of mixtures of antibodies
WO2005023849A2 (en) 2003-09-04 2005-03-17 Crucell Holland B.V. Antigenic peptides of rabies virus and uses thereof
JP4671864B2 (ja) * 2003-10-09 2011-04-20 中外製薬株式会社 タンパク質溶液の安定化方法
JP4762717B2 (ja) * 2003-10-09 2011-08-31 中外製薬株式会社 ＩｇＭ高濃度安定化溶液
EP1712240B1 (en) * 2003-12-25 2015-09-09 Kyowa Hakko Kirin Co., Ltd. Stable water-based medicinal preparation containing antibody
WO2005118644A2 (en) * 2004-05-27 2005-12-15 Crucell Holland B.V. Binding molecules capable of neutralizing rabies virus and uses thereof
ES2407468T3 (es) * 2005-04-18 2013-06-12 Yeda Research And Development Company Limited Formulaciones de anticuerpos anti-hepatitis B (HBV) estabilizadas
MX2009005414A (es) 2006-12-05 2009-06-01 Crucell Holland Bv Formulaciones liquidas de anticuerpo antirrabico.

Also Published As

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

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H11 Ip right ceased following rejected request for revival

Free format text: ST27 STATUS EVENT CODE: T-6-6-H10-H11-H101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: TIME LIMIT FOR REVERSAL EXPIRED

Effective date: 20240717