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

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (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 (2)
EP (1) EP3169710A1 (2)
JP (3) JP2017525680A (2)
AU (2) AU2015289874A1 (2)
CA (1) CA2954767A1 (2)
MX (1) MX2017000527A (2)
WO (1) WO2016010927A1 (2)

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 (7)

* 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
DK3596101T3 (da) 2017-03-14 2022-03-14 Amgen Inc Fremgangsmåder rettet mod krystallinske biomolekyler
EP3615065A1 (en) * 2017-04-28 2020-03-04 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
WO2018201064A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
EP3688024A4 (en) * 2017-09-26 2021-07-14 Biocon Biologics India Limited INTEGRATED AUTOMATED FILTRATION FOR SEPARATING, WASHING AND DRYING PEPTIDE CRYSTALS
GB2584687B (en) * 2019-06-11 2023-08-23 Univ Newcastle Crystallisation of chemical molecules

Family Cites Families (56)

* 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
US6451346B1 (en) 1998-12-23 2002-09-17 Amgen Inc Biodegradable pH/thermosensitive hydrogels for sustained delivery of biologically active agents
US6245740B1 (en) 1998-12-23 2001-06-12 Amgen Inc. Polyol:oil suspensions for the sustained release of proteins
KR20030074693A (ko) * 2000-12-28 2003-09-19 알투스 바이올로직스 인코포레이티드 전항체 및 이의 단편의 결정과 이의 제조 및 사용 방법
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
EA200901376A1 (ru) * 2007-04-13 2010-12-30 Новартис Аг Молекулы и способы модуляции пропротеинконвертазы субтилизинового/кексинового типа 9(pcsk9)
US20130072665A1 (en) * 2007-08-23 2013-03-21 Simon Mark Jackson Antigen binding proteins to proprotein convertase subtilisin kexin type 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)
MX2010011499A (es) * 2008-04-23 2010-11-12 Amgen Inc Variantes de proproteina neutralizante de convertasa subtilisina kexina de tipo 9 (pcsk9) y sus usos.
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
IN2012DN03824A (2) * 2009-10-30 2015-08-28 Merck Sharp & Dohme
JO3756B1 (ar) * 2010-11-23 2021-01-31 Regeneron Pharma اجسام مضادة بشرية لمستقبلات الجلوكاجون
SG192117A1 (en) * 2011-01-28 2013-08-30 Sanofi Sa Human antibodies to pcsk9 for use in methods of treating particular groups of subjects
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
US20150140005A1 (en) * 2012-05-17 2015-05-21 Cyon Therapeutics Inc. Methods and Uses for Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors
EP2861624A1 (en) * 2012-06-15 2015-04-22 F. Hoffmann-La Roche AG Anti-pcsk9 antibodies, formulations, dosing, and methods of use
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
TWI670279B (zh) * 2013-03-15 2019-09-01 Alder Biopharmaceuticals, Inc. 抗體純化及純度監測
WO2014150983A2 (en) * 2013-03-15 2014-09-25 Amgen Inc. Human antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9
US10494442B2 (en) * 2013-06-07 2019-12-03 Sanofi Biotechnology Methods for inhibiting atherosclerosis by administering an inhibitor of PCSK9
US20150004174A1 (en) * 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
CA2916259C (en) * 2013-06-28 2024-02-20 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
ES2914978T3 (es) * 2013-10-11 2022-06-20 Sanofi Biotechnology Uso de un inhibidor de PCSK9 para tratar hiperlipidemia
CN118105480A (zh) * 2013-11-12 2024-05-31 赛诺菲生物技术公司 用于与pcsk9抑制剂一起使用的给药方案
US8883157B1 (en) * 2013-12-17 2014-11-11 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
US9023359B1 (en) * 2014-07-15 2015-05-05 Kymab Limited 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
CA2935285A1 (en) * 2014-02-21 2015-08-27 Medimmune, Llc Anti-pcsk9-glp-1 fusions and methods for use
WO2015140079A1 (en) * 2014-03-17 2015-09-24 Sanofi Methods for treating subjects with primary hypercholesterolemia that is not adequately controlled
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
KR20230074283A (ko) * 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
WO2016046684A1 (en) * 2014-09-23 2016-03-31 Pfizer Inc. Treatment with anti-pcsk9 antibodies
EA039310B1 (ru) * 2015-02-26 2022-01-12 Санофи Байотекнолоджи Способы снижения сердечно-сосудистого риска
JP7074684B2 (ja) * 2016-04-08 2022-05-24 アムジエン・インコーポレーテツド 薬物送達デバイス、製造方法、及び使用方法
EP3448427A1 (en) * 2016-04-29 2019-03-06 CureVac AG Rna encoding an antibody
SG10201912565QA (en) * 2016-09-29 2020-02-27 Amgen Inc Low-viscosity antigen binding proteins and methods of making them
EP3522918A1 (en) * 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
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
MX2020003888A (es) * 2017-10-18 2020-11-06 Regenxbio Inc Anticuerpos terapeuticos postraduccionalmente modificados completamente humanos.
EP3833685A4 (en) * 2018-07-08 2022-08-17 Specifica Inc. ANTIBODY LIBRARIES WITH FEATURES FOR MAXIMIZED ANTIBODY DEVELOPMENT

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

Similar Documents

Publication Publication Date Title
US11267902B2 (en) Crystalline antibody formulations
US11773184B2 (en) Crystalline antibody formulations
US9920114B2 (en) Antibody formulations
HK1192570A (en) Anti-sclerostin antibody crystals and formulations thereof
HK1192570B (en) Anti-sclerostin antibody crystals and formulations thereof

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20200630

FZDE Discontinued

Effective date: 20221031