CL2020002519A1 - Composiciones de erenumab y usos de las mismas - Google Patents

Composiciones de erenumab y usos de las mismas

Info

Publication number
CL2020002519A1
CL2020002519A1 CL2020002519A CL2020002519A CL2020002519A1 CL 2020002519 A1 CL2020002519 A1 CL 2020002519A1 CL 2020002519 A CL2020002519 A CL 2020002519A CL 2020002519 A CL2020002519 A CL 2020002519A CL 2020002519 A1 CL2020002519 A1 CL 2020002519A1
Authority
CL
Chile
Prior art keywords
erenumab
compositions
variants
characterization
methods
Prior art date
Application number
CL2020002519A
Other languages
English (en)
Inventor
Kenneth Lawson
Noel Rieder
Suminda Hapuarachchi
Jose Gregorio Ramirez
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 CL2020002519A1 publication Critical patent/CL2020002519A1/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • 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
    • A61P25/06—Antimigraine agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/26—Conditioning of the fluid carrier; Flow patterns
    • G01N30/38—Flow patterns
    • G01N30/46—Flow patterns using more than one column
    • G01N30/461—Flow patterns using more than one column with serial coupling of separation columns
    • G01N30/463—Flow patterns using more than one column with serial coupling of separation columns for multidimensional chromatography
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Spectroscopy & Molecular Physics (AREA)

Abstract

La presente invención se refiere a composiciones que comprenden erenumab y una o más variantes de erenumab, incluyendo variantes de isomerización, variantes de desamidación, variantes ácidas y especies de HMW. También se describen formulaciones farmacéuticas que comprenden las composiciones de erenumab y métodos de uso y caracterización de las composiciones.
CL2020002519A 2018-04-02 2020-09-29 Composiciones de erenumab y usos de las mismas CL2020002519A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201862651651P 2018-04-02 2018-04-02

Publications (1)

Publication Number Publication Date
CL2020002519A1 true CL2020002519A1 (es) 2021-04-05

Family

ID=66248665

Family Applications (2)

Application Number Title Priority Date Filing Date
CL2020002519A CL2020002519A1 (es) 2018-04-02 2020-09-29 Composiciones de erenumab y usos de las mismas
CL2023000491A CL2023000491A1 (es) 2018-04-02 2023-02-17 Composiciones de erenumab y usos de las mismas (divisional de solicitud n° 02519-2020).

Family Applications After (1)

Application Number Title Priority Date Filing Date
CL2023000491A CL2023000491A1 (es) 2018-04-02 2023-02-17 Composiciones de erenumab y usos de las mismas (divisional de solicitud n° 02519-2020).

Country Status (19)

Country Link
US (2) US11407838B2 (es)
EP (1) EP3774881A1 (es)
JP (3) JP7840636B2 (es)
KR (2) KR20260109951A (es)
CN (1) CN111954678A (es)
AR (1) AR114722A1 (es)
AU (1) AU2019246983B2 (es)
BR (1) BR112020019882A2 (es)
CA (1) CA3095899A1 (es)
CL (2) CL2020002519A1 (es)
EA (1) EA202092335A1 (es)
IL (1) IL277663A (es)
MA (1) MA52202A (es)
MX (2) MX2020010320A (es)
PH (1) PH12020551618A1 (es)
SA (1) SA520420261B1 (es)
SG (1) SG11202009629YA (es)
TW (1) TWI847980B (es)
WO (1) WO2019195185A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3382B1 (ar) 2008-12-23 2019-03-13 Amgen Inc أجسام مضادة ترتبط مع مستقبل cgrp بشري
US11598756B2 (en) * 2020-01-30 2023-03-07 Regeneron Pharmaceuticals, Inc. Platform for native liquid chromatography-mass spectrometry
US20240209115A1 (en) * 2021-04-29 2024-06-27 Amgen Inc. Methods for reducing low molecular weight species of recombinantly-produced proteins
WO2023120561A1 (ja) * 2021-12-22 2023-06-29 中外製薬株式会社 生物活性が低下した抗体バリアント
CN115819589B (zh) * 2022-10-19 2026-06-19 武汉人福创新药物研发中心有限公司 一种培养基及生产抗cgrpr抗体的方法

Family Cites Families (59)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4560655A (en) 1982-12-16 1985-12-24 Immunex Corporation Serum-free cell culture medium and process for making same
US4657866A (en) 1982-12-21 1987-04-14 Sudhir Kumar Serum-free, synthetic, completely chemically defined tissue culture media
US4767704A (en) 1983-10-07 1988-08-30 Columbia University In The City Of New York Protein-free culture medium
GB8516415D0 (en) 1985-06-28 1985-07-31 Celltech Ltd Culture of animal cells
US4927762A (en) 1986-04-01 1990-05-22 Cell Enterprises, Inc. Cell culture medium with antioxidant
WO1990003430A1 (en) 1988-09-23 1990-04-05 Cetus Corporation Cell culture medium for enhanced cell growth, culture longevity and product expression
US5122469A (en) 1990-10-03 1992-06-16 Genentech, Inc. Method for culturing Chinese hamster ovary cells to improve production of recombinant proteins
AU673347B2 (en) 1992-03-17 1996-11-07 Novartis Ag Genetically engineered antibodies
DE69433747D1 (de) 1994-08-16 2004-06-03 Human Genome Sciences Inc Calcitoninrezeptor
US5785682A (en) 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
WO1998003534A1 (en) 1996-07-23 1998-01-29 Smithkline Beecham Corporation Calcitonin gene-related peptide receptor component factor (houdc44)
US6255455B1 (en) 1996-10-11 2001-07-03 The Trustees Of The University Of Pennsylvania Rh(D)-binding proteins and magnetically activated cell sorting method for production thereof
ATE370961T1 (de) 1998-05-06 2007-09-15 Genentech Inc Reinigung von antikörpern durch ionenaustauschchromatographie
ES2228052T3 (es) 1998-06-01 2005-04-01 Genentech, Inc. Separacion demonomeros de anticuerpos de sus multimeros utilizando cromatografia de intercambio de iones.
FR2821080B1 (fr) 2001-02-20 2003-12-19 Sanofi Synthelabo Anticorps specifique de l'adrenomedulline humaine, composition pharmaceutique le contenant, ses applications therapeutiques
DE60234944D1 (de) 2001-09-27 2010-02-11 Merck & Co Inc Isolierte dna-moleküle, die für einen humanisierten calcitonin gene-related peptide receptor kodiered assayverfahren
US7658924B2 (en) 2001-10-11 2010-02-09 Amgen Inc. Angiopoietin-2 specific binding agents
AR039067A1 (es) 2001-11-09 2005-02-09 Pfizer Prod Inc Anticuerpos para cd40
US20040132101A1 (en) 2002-09-27 2004-07-08 Xencor Optimized Fc variants and methods for their generation
US20040110170A1 (en) 2002-05-18 2004-06-10 The Regents Of The University Of California Cloning and characterization of calcitonin gene related peptide receptors
MXPA05001649A (es) 2002-08-12 2005-05-27 Birkir Sveinsson Uso de compuestos antagonistas del cgrp para tratamiento de la psoriasis.
US20040176577A1 (en) 2002-09-10 2004-09-09 Eva Rojer Immunoassays for specific determination of SCCA isoforms
WO2004097421A2 (en) 2003-04-29 2004-11-11 Bayer Healthcare Ag Diagnostics and therapeutics for diseases associated with calcitonin receptor-like receptor (calcrl)
KR20140011431A (ko) 2004-02-11 2014-01-28 아밀린 파마슈티칼스, 엘엘씨. 선택가능한 특성을 갖는 하이브리드 폴리펩티드
AU2005310305A1 (en) 2004-10-22 2006-06-08 Amgen Inc. Methods for refolding polypeptides
EP1805320B1 (en) 2004-10-22 2014-09-03 Amgen Inc. Methods for refolding of recombinant antibodies
US7423128B2 (en) 2004-11-03 2008-09-09 Amgen Fremont Inc. Anti-properdin antibodies, and methods for making and using same
ZA200705695B (en) 2004-12-21 2009-02-25 Astrazeneca Ab Antibodies directed to angiopoietin-2 and uses thereof
EP1900374B1 (en) 2005-06-16 2014-03-12 Takayuki Shindo Angiogenetic agent containing adrenomedulin as the active ingredient
GB0521139D0 (en) 2005-10-18 2005-11-23 Univ Sheffield Therapeutic agent
US8168592B2 (en) 2005-10-21 2012-05-01 Amgen Inc. CGRP peptide antagonists and conjugates
SI3045182T1 (en) 2005-11-14 2018-08-31 Teva Pharmaceuticals International Gmbh An antibody to a peptide-associated peptide antagonist to calcitonin for treating a headache in aggregates
WO2007076336A1 (en) 2005-12-22 2007-07-05 Eli Lilly And Company Treatment of migraine with anti-cgrp antibodies
WO2008112004A2 (en) 2006-08-03 2008-09-18 Astrazeneca Ab ANTIBODIES DIRECTED TO αVβ6 AND USES THEREOF
GB0708002D0 (en) 2007-04-25 2007-06-06 Univ Sheffield Antibodies
MX2010009724A (es) 2008-03-04 2010-09-28 Pfizer Ltd Procedimientos de tratamiento del dolor inflamatorio-.
FR2934597B1 (fr) 2008-07-31 2013-04-19 Univ Aix Marseille Ii Anticorps se liant aux recepteurs de l'adrenomedulline et leurs utilisations comme medicament.
CA2737045C (en) 2008-11-20 2017-11-14 Bruce Kabakoff Therapeutic protein formulations
JO3382B1 (ar) 2008-12-23 2019-03-13 Amgen Inc أجسام مضادة ترتبط مع مستقبل cgrp بشري
PE20120359A1 (es) * 2009-03-06 2012-04-13 Genentech Inc Formulacion con anticuerpo
JP5540095B2 (ja) * 2009-07-24 2014-07-02 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 抗体製造の最適化
BR112012004464B8 (pt) 2009-08-28 2021-05-25 Labrys Biologics Inc uso de um anticorpo antagonista anti-cgrp para preparar uma composição farmacêutica para tratar e/ou prevenir dor visceral e/ou um ou mais sintomas de dor visceral, em que a dor visceral está associada á cistite intersticial (ic), e dita composição farmacêutica
BR112012014937B1 (pt) 2009-12-18 2021-01-19 Novartis Ag método de produção de um anticorpo, fragmento de anticorpo ou proteína de fusão fc purificada usando uma matriz de cromatografia de afinidade
JOP20190250A1 (ar) 2010-07-14 2017-06-16 Regeneron Pharma صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب
CN108014334B (zh) 2011-05-20 2021-11-30 H.伦德贝克公司 抗cgrp抗体和抗体片段用于在有需要的受试者中预防或抑制畏光或厌光的用途
JP6292718B2 (ja) 2011-07-01 2018-03-14 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 凝集ポリペプチドから単量体ポリペプチドを分離するための方法
CA2857194A1 (en) 2011-12-07 2013-06-13 Thomas M. Dillon Igg2 disulfide isoform separation
EP2791176B1 (en) 2011-12-15 2018-07-11 Prestige Biopharma Pte. Ltd. A method of antibody purification
US9150645B2 (en) 2012-04-20 2015-10-06 Abbvie, Inc. Cell culture methods to reduce acidic species
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
KR102215405B1 (ko) 2013-03-15 2021-02-10 암젠 인크 인간 pac1 항체
TWI596107B (zh) * 2013-06-25 2017-08-21 卡地拉保健有限公司 單株抗體之新穎純化方法
KR102251127B1 (ko) * 2013-07-12 2021-05-11 제넨테크, 인크. 이온 교환 크로마토그래피 입력 최적화의 설명
US8946395B1 (en) 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography
MX378344B (es) 2014-03-21 2025-03-10 Teva Pharmaceuticals Int Gmbh Anticuerpos antagonistas dirigidos contra el peptido relacionado con el gen de calcitonina y metodos que usan los mismos.
US10556945B2 (en) 2014-03-21 2020-02-11 Teva Pharmaceuticals International Gmbh Antagonist antibodies directed against calcitonin gene-related peptide and methods using same
UY36302A (es) 2014-09-15 2016-04-29 Amgen Inc Proteína de unión a antígenos, bi-específicos del receptor anti-cgrp/receptor pac1 y usos de las mismas
TWI728953B (zh) 2015-04-24 2021-06-01 美商安美基公司 治療或預防偏頭痛之方法
AR104847A1 (es) 2015-06-17 2017-08-16 Lilly Co Eli Formulación de anticuerpo anti-cgrp

Also Published As

Publication number Publication date
US20190300617A1 (en) 2019-10-03
JP2023103323A (ja) 2023-07-26
CA3095899A1 (en) 2019-10-10
EA202092335A1 (ru) 2021-01-22
TW202003572A (zh) 2020-01-16
US11407838B2 (en) 2022-08-09
CN111954678A (zh) 2020-11-17
JP7840636B2 (ja) 2026-04-06
SA520420261B1 (ar) 2024-05-23
MX2020010320A (es) 2021-01-08
EP3774881A1 (en) 2021-02-17
IL277663A (en) 2020-11-30
JP2026034591A (ja) 2026-02-27
PH12020551618A1 (en) 2021-08-16
MA52202A (fr) 2021-02-17
AR114722A1 (es) 2020-10-07
WO2019195185A1 (en) 2019-10-10
KR20260109951A (ko) 2026-07-13
US20220348673A1 (en) 2022-11-03
BR112020019882A2 (pt) 2021-01-05
SG11202009629YA (en) 2020-10-29
JP2021519790A (ja) 2021-08-12
KR20200139720A (ko) 2020-12-14
MX2026003501A (es) 2026-05-04
AU2019246983A1 (en) 2020-10-29
CL2023000491A1 (es) 2023-10-13
TWI847980B (zh) 2024-07-11
AU2019246983B2 (en) 2025-12-18
KR102982529B1 (ko) 2026-06-25

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