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)
  • Virology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Communicable Diseases (AREA)
  • Oncology (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
EP06125400.9 2006-12-05
US60/872,892 2006-12-05
EP06125400 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
EP2322547A1 (en) 2003-06-25 2011-05-18 Crucell Holland B.V. Myeloid cell-specific lectin
EP2314620B1 (en) * 2004-05-27 2013-06-05 Crucell Holland B.V. Method of identifying binding molecules capable of neutralizing rabies virus
CA2881717C (en) * 2006-06-06 2018-06-12 Cecilia Anna Wilhelmina Geuijen Human binding molecules having killing activity against staphylococci and uses thereof
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
CN107233569B (zh) 2011-10-25 2021-08-31 普罗西纳生物科学有限公司 抗体制剂和方法
RS55417B1 (sr) * 2012-03-07 2017-04-28 Lilly Co Eli Formulacija il-17 antitela
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
JP7382232B2 (ja) 2017-05-02 2023-11-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
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
WO2020081408A1 (en) 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
MX2021004928A (es) 2018-10-31 2021-06-08 Merck Sharp & Dohme Llc Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos.
EP3876990A4 (en) 2018-11-07 2023-09-06 Merck Sharp & Dohme LLC CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES
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
ATE99958T1 (de) 1989-06-08 1994-01-15 Wistar Inst Monoklonale antikoerper zur behandlung nach einem kontakt mit tollwutvirus.
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
WO2003016501A2 (en) 2001-08-21 2003-02-27 Thomas Jefferson University Recombinant antibodies, and compositions and methods for making and using the same
DK2314629T4 (da) 2002-07-18 2023-02-06 Merus Nv Rekombinant produktion af blandinger af antistoffer
WO2005023849A2 (en) 2003-09-04 2005-03-17 Crucell Holland B.V. Antigenic peptides of rabies virus and uses thereof
EP1686137A4 (en) * 2003-10-09 2009-10-28 Chugai Pharmaceutical Co Ltd Method of stabilizing protein solutions
EP1688432B1 (en) * 2003-10-09 2011-08-03 Chugai Seiyaku Kabushiki Kaisha Igm high concentration stabilized solution
EP1712240B1 (en) * 2003-12-25 2015-09-09 Kyowa Hakko Kirin Co., Ltd. Stable water-based medicinal preparation containing antibody
EP2314620B1 (en) * 2004-05-27 2013-06-05 Crucell Holland B.V. Method of identifying binding molecules capable of neutralizing rabies virus
EP1871803B1 (en) * 2005-04-18 2013-02-20 Yeda Research And Development Company Limited Stabilized anti-hepatitis b (hbv) antibody formulations
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
IL199004A0 (en) 2010-02-17
CN101557799B (zh) 2012-08-22
ZA200902772B (en) 2012-09-26
IL199004A (en) 2015-10-29
EA200970533A1 (ru) 2009-10-30
WO2008068246A1 (en) 2008-06-12
JP2010511665A (ja) 2010-04-15
MX2009005414A (es) 2009-06-01
JP5410985B2 (ja) 2014-02-05
CA2668947A1 (en) 2008-06-12
US20100034829A1 (en) 2010-02-11
EA017549B1 (ru) 2013-01-30
CU23795A3 (es) 2012-03-15
EP2088997B1 (en) 2016-08-24
AU2007328960B2 (en) 2013-01-17
KR101522036B1 (ko) 2015-05-20
AU2007328960A1 (en) 2008-06-12
US7959922B2 (en) 2011-06-14
CN101557799A (zh) 2009-10-14
EP2088997A1 (en) 2009-08-19
KR20090089881A (ko) 2009-08-24

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EEER Examination request
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