CA2668947C - Liquid anti-rabies antibody formulations - Google Patents

Liquid anti-rabies antibody formulations Download PDF

Info

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

Links

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)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (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
EP06125400 2006-12-05
US60/872,892 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
NZ543635A (en) 2003-06-25 2008-05-30 Crucell Holland Bv Human C-type lectin: a suitable target molecule for binding molecules, particularly immunoconjugates, in the diagnosis, prevention and/or treatment of myeloid neoplastic diseases such as AML and CML
PL2314621T3 (pl) * 2004-05-27 2014-08-29 Crucell Holland Bv Cząsteczki wiążące zdolne do neutralizowania wirusa wścieklizny i ich zastosowania
DK2027155T3 (en) * 2006-06-06 2016-05-09 Crucell Holland Bv HUMAN BINDING MOLECULES with killer activity against staphylococci and uses thereof
WO2008068246A1 (en) 2006-12-05 2008-06-12 Crucell Holland B.V. Liquid anti-rabies antibody formulations
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
WO2011028961A2 (en) 2009-09-04 2011-03-10 Xoma Technology Ltd. Anti-botulism antibody coformulations
BR112014009866A2 (pt) 2011-10-25 2018-09-04 Onclave Therapeutics Limited formulações de anticorpos e métodos
CA2866128C (en) 2012-03-07 2017-02-28 Eli Lilly And Company Il-17 antibody formulation
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
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
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
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
JP7895285B2 (ja) 2020-06-12 2026-07-27 ナンチン リーズ バイオラブス カンパニー，リミティド Ｔｎｆｒ２に結合する抗体およびその用途
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
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
EP0934526B1 (en) 1996-10-08 2003-01-08 U-BISys B.V. Methods and means for selecting peptides and proteins having specific affinity for a target
US20040013672A1 (en) * 2000-05-16 2004-01-22 Thomas Jefferson University Recombinant antibodies, and compositions and methods for making and using the same
ATE557040T1 (de) 2001-08-21 2012-05-15 Univ Jefferson Rekombinante antikörper sowie zusammensetzungen und verfahren zu deren herstellung und verwendung
NZ537277A (en) 2002-07-18 2008-04-30 Crucell Holland Bv Recombinant production of mixtures of antibodies
AU2004270409A1 (en) * 2003-09-04 2005-03-17 Crucell Holland B.V. Antigenic peptides of rabies virus and uses thereof
WO2005035574A1 (ja) * 2003-10-09 2005-04-21 Chugai Seiyaku Kabushiki Kaisha IgM高濃度安定化溶液
WO2005035573A1 (ja) * 2003-10-09 2005-04-21 Chugai Seiyaku Kabushiki Kaisha タンパク質溶液の安定化方法
WO2005063291A1 (ja) * 2003-12-25 2005-07-14 Kirin Beer Kabushiki Kaisha 抗体を含有する安定な水性医薬製剤
PL2314621T3 (pl) * 2004-05-27 2014-08-29 Crucell Holland Bv Cząsteczki wiążące zdolne do neutralizowania wirusa wścieklizny i ich zastosowania
ES2407468T3 (es) * 2005-04-18 2013-06-12 Yeda Research And Development Company Limited Formulaciones de anticuerpos anti-hepatitis B (HBV) estabilizadas
WO2008068246A1 (en) 2006-12-05 2008-06-12 Crucell Holland B.V. Liquid anti-rabies antibody formulations

Also Published As

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

Similar Documents

Publication Publication Date Title
EP2088997B1 (en) Liquid anti-rabies antibody formulations
AU2022291595B2 (en) Stable, aqueous antibody formulations
US12565526B2 (en) Formulations of anti-RSV antibodies and methods of use thereof
RU2644214C2 (ru) СТАБИЛЬНЫЕ ПРЕПАРАТЫ СВЯЗЫВАЮЩЕГО СРЕДСТВА НА ОСНОВЕ IgG4
AU2013334740A1 (en) Stable, low viscosity antibody formulation
JP2020534255A (ja) 治療用タンパク質の凍結乾燥医薬配合物のためのプロセス
CN116077646B (zh) 一种抗冠状病毒s蛋白的抗体制剂及其制备方法和用途
AU2020325569B2 (en) Process for preparing a composition comprising a protein D polypeptide
ES2602275T3 (es) Formulaciones líquidas de anticuerpo anti-rabia
CA3115708C (en) Formulations of anti-rsv antibodies and methods of use thereof
RU2807524C2 (ru) Составы антител к rsv и способы их применения
BR112020004902B1 (pt) Processo para formulação farmacêutica liofilizada de uma proteína terapêutica

Legal Events

Date Code Title Description
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