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

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/38Flow patterns
    • G01N30/46Flow patterns using more than one column
    • G01N30/461Flow patterns using more than one column with serial coupling of separation columns
    • G01N30/463Flow patterns using more than one column with serial coupling of separation columns for multidimensional chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N2030/022Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027Liquid chromatography

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (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) JP2021519790A (es)
KR (1) KR20200139720A (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 (1) 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 (3)

* 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
KR102902883B1 (ko) * 2021-12-22 2025-12-22 추가이 세이야쿠 가부시키가이샤 생물 활성이 저하된 항체 배리언트
CN115819589A (zh) * 2022-10-19 2023-03-21 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
DE68925971T2 (de) 1988-09-23 1996-09-05 Cetus Oncology Corp Zellenzuchtmedium für erhöhtes zellenwachstum, zur erhöhung der langlebigkeit und expression der produkte
US5122469A (en) 1990-10-03 1992-06-16 Genentech, Inc. Method for culturing Chinese hamster ovary cells to improve production of recombinant proteins
CA2130173A1 (en) 1992-03-17 1993-09-30 Norman Hardman Genetically engineered antibodies
ATE265466T1 (de) 1994-08-16 2004-05-15 Human Genome Sciences Inc Calcitoninrezeptor
US5785682A (en) 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
AU6596096A (en) 1996-07-23 1998-02-10 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
ES2292682T3 (es) 1998-05-06 2008-03-16 Genentech, Inc. Purificacion de anticuerpos mediante cromatografia de intercambio ionico.
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
JP4603261B2 (ja) 2001-09-27 2010-12-22 メルク・シャープ・エンド・ドーム・コーポレイション ヒト化カルシトニン遺伝子関連ペプチド受容体をコードする単離dna分子、関連する非ヒトトランスジェニック動物及びアッセイ方法
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
PL375536A1 (en) 2002-08-12 2005-11-28 Birkir Sveinsson Use of cgrp antagonist compounds for treatment of 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)
BRPI0507594A (pt) 2004-02-11 2007-07-03 Amylin Pharmaceuticals Inc polipetìdeos hìbridos com propriedades selecionáveis
NZ554520A (en) 2004-10-22 2010-03-26 Amgen Inc Methods for refolding of recombinant antibodies
EP1805205A1 (en) 2004-10-22 2007-07-11 Amgen Inc. Methods for refolding polypeptides
US7423128B2 (en) 2004-11-03 2008-09-09 Amgen Fremont Inc. Anti-properdin antibodies, and methods for making and using same
WO2006068953A2 (en) 2004-12-21 2006-06-29 Astrazeneca Ab Antibodies directed to angiopoietin-2 and uses thereof
US9072777B2 (en) 2005-06-16 2015-07-07 Takayuki Shindo Method for screening substance having proangiogenic effect
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
JP5123197B2 (ja) 2005-11-14 2013-01-16 ライナット ニューロサイエンス コーポレイション カルシトニン遺伝子関連ペプチドに対するアンタゴニスト抗体およびその使用方法
WO2007076336A1 (en) 2005-12-22 2007-07-05 Eli Lilly And Company Treatment of migraine with anti-cgrp antibodies
EP2064244B1 (en) 2006-08-03 2019-06-05 MedImmune Limited ANTIBODIES DIRECTED TO alphaVbeta6 AND USES THEREOF
GB0708002D0 (en) 2007-04-25 2007-06-06 Univ Sheffield Antibodies
DK2265288T3 (en) 2008-03-04 2016-06-06 Labrys Biologics Inc Methods for the treatment of inflammatory pain
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.
KR101676887B1 (ko) * 2008-11-20 2016-11-16 제넨테크, 인크. 치료 단백질 제형
JO3382B1 (ar) 2008-12-23 2019-03-13 Amgen Inc أجسام مضادة ترتبط مع مستقبل cgrp بشري
AU2010221156A1 (en) * 2009-03-06 2011-09-22 Genentech, Inc. Antibody formulation
BRPI1010119A2 (pt) * 2009-07-24 2016-03-15 Hoffmann La Roche "método de produção de composição de anticorpo e uso de cromatografia de troca de íons analítica"
KR101519192B1 (ko) 2009-08-28 2015-05-11 리나트 뉴로사이언스 코프. 칼시토닌 유전자-관련된 펩티드에 대해 지시된 길항제 항체의 투여에 의한 내장 통증의 치료 방법
CA2784278C (en) 2009-12-18 2019-02-26 Novartis Ag Wash solution and method for affinity chromatography
JOP20190250A1 (ar) 2010-07-14 2017-06-16 Regeneron Pharma صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب
NZ732970A (en) 2011-05-20 2022-08-26 H Lundbeck As Use of anti-cgrp antibodies and antibody fragments to prevent or inhibit photophobia or light aversion in subjects in need thereof, especially migraine sufferers
WO2013004587A1 (en) 2011-07-01 2013-01-10 F. Hoffmann-La Roche Ag Method for separation of monomeric polypeptides from aggregated polypeptides
JP2015502959A (ja) * 2011-12-07 2015-01-29 アムジェン インコーポレイテッド IgG2ジスルフィドアイソフォームの分離
ES2690213T3 (es) * 2011-12-15 2018-11-19 Prestige Biopharma Pte. Ltd. Un método de purificación de anticuerpos
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9334319B2 (en) 2012-04-20 2016-05-10 Abbvie Inc. Low acidic species compositions
TWI636064B (zh) 2013-03-15 2018-09-21 安美基公司 人類pac1抗體
AR096713A1 (es) * 2013-06-25 2016-01-27 Cadila Healthcare Ltd Proceso de purificación para anticuerpos monoclonales
HRP20190071T1 (hr) * 2013-07-12 2019-02-22 F. Hoffmann - La Roche Ag Elucidacija optimizacije unosa kromatografijom ionske izmjene
US8946395B1 (en) 2013-10-18 2015-02-03 Abbvie Inc. Purification of proteins using hydrophobic interaction chromatography
US10556945B2 (en) 2014-03-21 2020-02-11 Teva Pharmaceuticals International Gmbh Antagonist antibodies directed against calcitonin gene-related peptide and methods using same
HRP20240159T1 (hr) 2014-03-21 2024-04-12 Teva Pharmaceuticals International Gmbh Antagonistička protutijela usmjerena protiv peptida povezanog s genom kalcitonina i postupci koji ih koriste
CA2960756C (en) 2014-09-15 2023-08-01 Amgen Inc. Bi-specific anti-cgrp receptor/pac1 receptor antigen binding proteins and uses thereof
TWI799849B (zh) * 2015-04-24 2023-04-21 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
PH12020551618A1 (en) 2021-08-16
AU2019246983B2 (en) 2025-12-18
BR112020019882A2 (pt) 2021-01-05
US20190300617A1 (en) 2019-10-03
MX2020010320A (es) 2021-01-08
AR114722A1 (es) 2020-10-07
SA520420261B1 (ar) 2024-05-23
SG11202009629YA (en) 2020-10-29
AU2019246983A1 (en) 2020-10-29
CN111954678A (zh) 2020-11-17
WO2019195185A1 (en) 2019-10-10
JP2023103323A (ja) 2023-07-26
CA3095899A1 (en) 2019-10-10
US11407838B2 (en) 2022-08-09
KR20200139720A (ko) 2020-12-14
CL2023000491A1 (es) 2023-10-13
TWI847980B (zh) 2024-07-11
JP2026034591A (ja) 2026-02-27
EA202092335A1 (ru) 2021-01-22
JP2021519790A (ja) 2021-08-12
EP3774881A1 (en) 2021-02-17
US20220348673A1 (en) 2022-11-03
MA52202A (fr) 2021-02-17
IL277663A (en) 2020-11-30
TW202003572A (zh) 2020-01-16

Similar Documents

Publication Publication Date Title
CL2019000793A1 (es) Moduladores de calpaínas y usos terapéuticos de los mismos.
CO2020000145A2 (es) Carboxamidas como moduladores de los canales de sodio
CL2017002727A1 (es) Composiciones de ácido obeticólico y métodos de uso
BR112022012410A2 (pt) Degradadores smarca e usos dos mesmos
SV2018005643A (es) Composiciones de insulina de rapida accion
MX2020010881A (es) Construcciones de anticuerpos anti-ror.
BR112017018368A2 (pt) composições contendo rna para o tratamento de doenças tumorais
CL2023000491A1 (es) Composiciones de erenumab y usos de las mismas (divisional de solicitud n° 02519-2020).
MX2021004331A (es) Composiciones estables de semaglutida y usos de las mismas.
CL2019001053A1 (es) Formulaciones farmacéuticas y métodos para prepararlas.
MX2020001885A (es) Formulaciones de daptomicina.
BR112018013761A2 (pt) compostos antiproliferativos e suas composições farmacêuticas e usos
MX2020002123A (es) Sales de ribociclib y formas en estado sólido de las mismas.
MX387731B (es) Composiciones farmacéuticas orales de mesalazina.
CL2019002729A1 (es) Formulaciones de ácido 1-amino-1-ciclopropanocarboxílico.
MX2019005925A (es) Composiciones de alergenos liquidas y metodos para la preparacion de las mismas.
ZA202102816B (en) High concentration protein formulation
CO2019009020A2 (es) Derivados de pirazol como inhibidores de bromodominio.
BR112022010143A2 (pt) Inibidores de ahr e usos respectivos
MX2018009364A (es) Sal de succinato de citisina y uso de la misma.
EA201991319A1 (ru) Вакцины аттенуированного свиного гриппа и способы их изготовления и применения
MX2021007032A (es) Derivados activos de éster de testosterona, composiciones y usos de los mismos.
MX2019015869A (es) Nuevas formulaciones orales de belinostat.
EA201892157A1 (ru) Фосфаплатиновые жидкие составы
EA202191345A1 (ru) Стабильный состав глюкокортикоидов