CA2954767A1 - Crystalline antibody formulations - Google Patents

Crystalline antibody formulations Download PDF

Info

Publication number
CA2954767A1
CA2954767A1 CA2954767A CA2954767A CA2954767A1 CA 2954767 A1 CA2954767 A1 CA 2954767A1 CA 2954767 A CA2954767 A CA 2954767A CA 2954767 A CA2954767 A CA 2954767A CA 2954767 A1 CA2954767 A1 CA 2954767A1
Authority
CA
Canada
Prior art keywords
antibody
seq
phosphate
crystals
sodium
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.)
Abandoned
Application number
CA2954767A
Other languages
English (en)
French (fr)
Inventor
Nazer Khalaf
Saraswathi MANDAPATI
Reena J. Patel
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 CA2954767A1 publication Critical patent/CA2954767A1/en
Abandoned legal-status Critical Current

Links

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)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Diabetes (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)
CA2954767A 2014-07-14 2015-07-13 Crystalline antibody formulations Abandoned CA2954767A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462024393P 2014-07-14 2014-07-14
US62/024,393 2014-07-14
PCT/US2015/040217 WO2016010927A1 (en) 2014-07-14 2015-07-13 Crystalline antibody formulations

Publications (1)

Publication Number Publication Date
CA2954767A1 true CA2954767A1 (en) 2016-01-21

Family

ID=53836192

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2954767A Abandoned CA2954767A1 (en) 2014-07-14 2015-07-13 Crystalline antibody formulations

Country Status (7)

Country Link
US (2) US20170198059A1 (enExample)
EP (1) EP3169710A1 (enExample)
JP (3) JP2017525680A (enExample)
AU (2) AU2015289874A1 (enExample)
CA (1) CA2954767A1 (enExample)
MX (1) MX2017000527A (enExample)
WO (1) WO2016010927A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11267902B2 (en) * 2014-07-14 2022-03-08 Amgen Inc. Crystalline antibody formulations

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2954773C (en) * 2014-07-14 2023-10-03 Amgen Inc. Crystalline antibody formulations
US20170056504A1 (en) * 2015-09-02 2017-03-02 Kenneth I. Kohn Method of extending half-life of crystaline antibodies
EP3596101B1 (en) 2017-03-14 2022-01-05 Amgen Inc. Methods directed to crystalline biomolecules
US12103979B2 (en) 2017-04-28 2024-10-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
MA48461A (fr) * 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
CN111386281B (zh) * 2017-09-26 2024-03-19 拜康生物制品印度有限公司 用于肽晶体的分离、洗涤和干燥的集成的自动化过滤
GB2584687B (en) * 2019-06-11 2023-08-23 Univ Newcastle Crystallisation of chemical molecules
CN113912622B (zh) 2020-07-10 2023-12-01 上海纽思克生物科技有限公司 三环嘧啶酮类化合物、其制备方法、其组合物和用途

Family Cites Families (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU698393B2 (en) 1994-06-24 1998-10-29 Immunex Corporation Controlled release polypeptide compositions and methods of treating inflammatory bowel disease
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
EP1345968A2 (en) * 2000-12-28 2003-09-24 Altus Biologics Inc. Crystals of whole antibodies and fragments thereof and methods for making and using them
US8821086B2 (en) * 2006-12-22 2014-09-02 Tennine Corporation Method and apparatus for controlled-fracture machining
WO2008109871A2 (en) * 2007-03-08 2008-09-12 Irm Llc Crystal structure of proprotein convertase 9 (pcsk9) and uses thereof
AR066042A1 (es) * 2007-04-13 2009-07-22 Novartis Ag Moleculas y metodos para modular la proteina convertasa-subtilisina /quexina tipo 9 (pcsk9)
JOP20080381B1 (ar) * 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
US20130072665A1 (en) * 2007-08-23 2013-03-21 Simon Mark Jackson Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (pcsk9)
EP2296694B1 (en) * 2008-04-23 2015-08-05 Amgen Inc. Neutralizing proprotein convertase subtilisin kexin type 9 (pcsk9) variants and uses thereof
KR100985090B1 (ko) * 2008-05-23 2010-10-04 한국과학기술연구원 크라이센 노출 여부 확인용 바이오마커 및 이를 이용한확인 방법
WO2011028938A1 (en) * 2009-09-02 2011-03-10 Alnylam Pharmaceuticals, Inc. Methods for lowering serum cholestrol in a subject using inhibition of pcsk9
JO3244B1 (ar) 2009-10-26 2018-03-08 Amgen Inc بروتينات ربط مستضادات il – 23 البشرية
AU2010313324A1 (en) * 2009-10-30 2012-04-12 Merck Sharp & Dohme Corp. AX213 and AX132 PCSK9 antagonists and variants
JO3756B1 (ar) * 2010-11-23 2021-01-31 Regeneron Pharma اجسام مضادة بشرية لمستقبلات الجلوكاجون
CA2825778A1 (en) * 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
JOP20200043A1 (ar) * 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
US20140004122A1 (en) * 2011-05-10 2014-01-02 Amgen Inc. Methods for treating or preventing cholesterol related disorders
ITPN20110039A1 (it) * 2011-05-24 2012-11-25 Keyline S P A Blocchetto di presa perfezionato per macchina duplicatrice di chiavi
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
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
US9255154B2 (en) * 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
WO2013170367A1 (en) * 2012-05-17 2013-11-21 The University Of British Columbia Methods and uses for proprotein convert ase subtilisin kexin 9 (pcsk9) inhibitors
AR091462A1 (es) * 2012-06-15 2015-02-04 Genentech Inc Anticuerpos anti-pcsk9, formulaciones, dosificacion y metodos de uso
US20150335615A1 (en) * 2013-01-04 2015-11-26 Toshihisa Kawai Cholesterol-lowering compounds in combination with lipid metabolism-altering compounds of non-absorbable sugars, compounds that convert nh3 to nh4+, or hydrogen-generating compounds for the treatment of high cholesterol and inflammation
WO2014145744A1 (en) * 2013-03-15 2014-09-18 Alder Biopharmaceuticals, Inc. Antibody purification and purity monitoring
AU2014235430A1 (en) * 2013-03-15 2015-09-24 Amgen Inc. Human antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (PCSK9)
TW201534324A (zh) * 2013-06-07 2015-09-16 Sanofi Sa 藉由投與ｐｃｓｋ９抑制劑抑制動脈粥狀硬化的方法
JP6267792B2 (ja) * 2013-06-28 2018-01-24 アムジエン・インコーポレーテツド ホモ接合性家族性高コレステロール血症の治療方法
US20150004174A1 (en) * 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
MX373298B (es) * 2013-10-11 2020-05-20 Sanofi Biotechnology Uso de un inhibidor de pcsk9 para tratar la hiperlipidemia.
US10428157B2 (en) * 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
US8883157B1 (en) * 2013-12-17 2014-11-11 Kymab Limited Targeting rare human PCSK9 variants for cholesterol treatment
US9023359B1 (en) * 2014-07-15 2015-05-05 Kymab Limited Targeting rare human PCSK9 variants for cholesterol treatment
US9034332B1 (en) * 2014-07-15 2015-05-19 Kymab Limited Precision medicine by targeting rare human PCSK9 variants for cholesterol treatment
EA201691320A1 (ru) * 2014-02-14 2016-11-30 Ридженерон Фармасьютикалз, Инк. Способы лечения пациентов с гиперхолестеринемией, которая устойчива к терапии умеренными дозами статинов
BR112016017402A2 (pt) * 2014-02-21 2017-10-17 Medimmune Ltd fusões anti-pcsk9~glp-1 e métodos para uso
CN114558129A (zh) * 2014-03-17 2022-05-31 赛诺菲生物技术公司 用于降低心血管风险的方法
US20150283236A1 (en) * 2014-03-17 2015-10-08 Marie Baccara-Dinet Methods for treating subjects with primary hypercholesterolemia that is not adequately controlled
CA2954773C (en) * 2014-07-14 2023-10-03 Amgen Inc. Crystalline antibody formulations
US20170198059A1 (en) * 2014-07-14 2017-07-13 Amgen Inc. Crystalline antibody formulations
KR20230074283A (ko) * 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
EP3197492A1 (en) * 2014-09-23 2017-08-02 Pfizer Inc Treatment with anti-pcsk9 antibodies
EP3439715B1 (en) * 2016-04-08 2021-03-10 Amgen Inc. Drug delivery device
US11596699B2 (en) * 2016-04-29 2023-03-07 CureVac SE RNA encoding an antibody
IL307684B2 (en) * 2016-09-29 2025-04-01 Amgen Inc Low viscosity antigen binding proteins and methods for preparing them
JP7275027B2 (ja) * 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
JOP20190112A1 (ar) * 2016-11-14 2019-05-14 Amgen Inc علاجات مدمجة لتصلب الشرايين، شاملة مرض قلبي وعائي تصلبي
US20190031774A1 (en) * 2017-06-09 2019-01-31 Sanofi Biotechnology Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor
KR20200067195A (ko) * 2017-10-18 2020-06-11 리젠엑스바이오 인크. 완전-인간 번역후 변형된 항체 치료제
WO2020014143A1 (en) * 2018-07-08 2020-01-16 Specifica Inc. Antibody libraries with maximized antibody developability characteristics

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11267902B2 (en) * 2014-07-14 2022-03-08 Amgen Inc. Crystalline antibody formulations

Also Published As

Publication number Publication date
AU2021201422A1 (en) 2021-03-25
JP2017525680A (ja) 2017-09-07
JP2018150337A (ja) 2018-09-27
US20190127485A1 (en) 2019-05-02
EP3169710A1 (en) 2017-05-24
WO2016010927A1 (en) 2016-01-21
AU2015289874A1 (en) 2017-02-02
US11267902B2 (en) 2022-03-08
JP2020172526A (ja) 2020-10-22
US20170198059A1 (en) 2017-07-13
MX2017000527A (es) 2017-08-10

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20200630

FZDE Discontinued

Effective date: 20221031