CA2954773C - Crystalline antibody formulations - Google Patents

Crystalline antibody formulations Download PDF

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Publication number
CA2954773C
CA2954773C CA2954773A CA2954773A CA2954773C CA 2954773 C CA2954773 C CA 2954773C CA 2954773 A CA2954773 A CA 2954773A CA 2954773 A CA2954773 A CA 2954773A CA 2954773 C CA2954773 C CA 2954773C
Authority
CA
Canada
Prior art keywords
seq
sodium
antibody
sequence
crystals
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
CA2954773A
Other languages
English (en)
French (fr)
Other versions
CA2954773A1 (en
Inventor
Twinkle R. Christian
Christi L. Clogston
Timothy David Osslund
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.)
Amgen Inc
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of CA2954773A1 publication Critical patent/CA2954773A1/en
Application granted granted Critical
Publication of CA2954773C publication Critical patent/CA2954773C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
CA2954773A 2014-07-14 2015-07-13 Crystalline antibody formulations Active CA2954773C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462024399P 2014-07-14 2014-07-14
US62/024,399 2014-07-14
PCT/US2015/040211 WO2016010924A1 (en) 2014-07-14 2015-07-13 Crystalline antibody formulations

Publications (2)

Publication Number Publication Date
CA2954773A1 CA2954773A1 (en) 2016-01-21
CA2954773C true CA2954773C (en) 2023-10-03

Family

ID=53716611

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2954773A Active CA2954773C (en) 2014-07-14 2015-07-13 Crystalline antibody formulations

Country Status (7)

Country Link
US (2) US10611850B2 (https=)
EP (2) EP3169709B1 (https=)
JP (4) JP6783223B2 (https=)
AU (3) AU2015289967A1 (https=)
CA (1) CA2954773C (https=)
MX (2) MX382864B (https=)
WO (1) WO2016010924A1 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
ES2985784T3 (es) 2011-11-18 2024-11-07 Regeneron Pharma Micropartículas de proteínas recubiertas con polímeros para formulaciones de liberación prolongada para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
EA039663B1 (ru) 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
AU2015289874A1 (en) * 2014-07-14 2017-02-02 Amgen Inc. Crystalline antibody formulations
CA2954773C (en) * 2014-07-14 2023-10-03 Amgen Inc. Crystalline antibody formulations
EP3362041B1 (en) * 2015-10-16 2026-04-08 Regeneron Pharmaceuticals, Inc. Stable protein compositions
WO2019099427A1 (en) * 2017-11-14 2019-05-23 The University Of North Carolina At Chapel Hill Compositions and methods for stabilization of proteins
GB2584687B (en) * 2019-06-11 2023-08-23 Univ Newcastle Crystallisation of chemical molecules

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10503179A (ja) 1994-06-24 1998-03-24 イミュネックス・コーポレーション 放出制御性ポリペプチド組成物および炎症性腸疾患の治療方法
IL112834A (en) 1995-03-01 2000-12-06 Yeda Res & Dev Pharmaceutical compositions for controlled release of soluble receptors
US6020004A (en) 1997-04-17 2000-02-01 Amgen Inc. Biodegradable microparticles for the sustained delivery of therapeutic drugs
US6541606B2 (en) 1997-12-31 2003-04-01 Altus Biologics Inc. Stabilized protein crystals formulations containing them and methods of making them
US6432449B1 (en) 1998-05-18 2002-08-13 Amgen Inc. Biodegradable sustained-release alginate gels
US6541033B1 (en) 1998-06-30 2003-04-01 Amgen Inc. Thermosensitive biodegradable hydrogels for sustained delivery of leptin
US6245740B1 (en) 1998-12-23 2001-06-12 Amgen Inc. Polyol:oil suspensions for the sustained release of proteins
US6451346B1 (en) 1998-12-23 2002-09-17 Amgen Inc Biodegradable pH/thermosensitive hydrogels for sustained delivery of biologically active agents
KR20030074693A (ko) * 2000-12-28 2003-09-19 알투스 바이올로직스 인코포레이티드 전항체 및 이의 단편의 결정과 이의 제조 및 사용 방법
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
EA039663B1 (ru) * 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
CA2954773C (en) * 2014-07-14 2023-10-03 Amgen Inc. Crystalline antibody formulations
AU2015289874A1 (en) * 2014-07-14 2017-02-02 Amgen Inc. Crystalline antibody formulations

Also Published As

Publication number Publication date
EP3169709A1 (en) 2017-05-24
JP2017525679A (ja) 2017-09-07
MX2021006003A (es) 2021-07-06
MX2017000526A (es) 2017-08-02
JP6783223B2 (ja) 2020-11-11
JP2020169200A (ja) 2020-10-15
JP2018141004A (ja) 2018-09-13
AU2024205016A1 (en) 2024-08-15
US11773184B2 (en) 2023-10-03
US20200299410A1 (en) 2020-09-24
US20170198058A1 (en) 2017-07-13
JP7264853B2 (ja) 2023-04-25
MX382864B (es) 2025-03-13
US10611850B2 (en) 2020-04-07
AU2015289967A1 (en) 2017-02-02
JP2023055977A (ja) 2023-04-18
WO2016010924A1 (en) 2016-01-21
CA2954773A1 (en) 2016-01-21
AU2021201409A1 (en) 2021-03-25
EP3169709B1 (en) 2021-05-12
EP3929218A1 (en) 2021-12-29

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