ECSP19062769A - Formulación de anticuerpo monoclonal anti-vrs - Google Patents

Formulación de anticuerpo monoclonal anti-vrs

Info

Publication number
ECSP19062769A
ECSP19062769A ECSENADI201962769A ECDI201962769A ECSP19062769A EC SP19062769 A ECSP19062769 A EC SP19062769A EC SENADI201962769 A ECSENADI201962769 A EC SENADI201962769A EC DI201962769 A ECDI201962769 A EC DI201962769A EC SP19062769 A ECSP19062769 A EC SP19062769A
Authority
EC
Ecuador
Prior art keywords
vrs
monoclonal anti
antibody formulation
formulation
present
Prior art date
Application number
ECSENADI201962769A
Other languages
English (en)
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 filed Critical
Publication of ECSP19062769A publication Critical patent/ECSP19062769A/es

Links

Classifications

    • 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
    • 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
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002—Coronaviridae
    • C07K16/1003—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027—Paramyxoviridae, e.g. respiratory syncytial virus
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • 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
    • 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]
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención proporciona una formulación que comprende: (i) un anticuerpo monoclonal anti-VRS; y (ii) un excipiente iónico; en donde el anticuerpo monoclonal está presente a una concentración de aproximadamente 50 mg/ml o más y el excipiente iónico está presente a una concentración de entre 50 y 150 mM y la formulación tiene un pH de aproximadamente 5.5 a aproximadamente 7.5.
ECSENADI201962769A 2017-03-01 2019-08-29 Formulación de anticuerpo monoclonal anti-vrs ECSP19062769A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01

Publications (1)

Publication Number Publication Date
ECSP19062769A true ECSP19062769A (es) 2019-09-30

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSENADI201962769A ECSP19062769A (es) 2017-03-01 2019-08-29 Formulación de anticuerpo monoclonal anti-vrs

Country Status (22)

Country Link
US (4) US10774133B2 (es)
EP (1) EP3589648A4 (es)
JP (2) JP7046088B2 (es)
KR (2) KR102359181B1 (es)
CN (3) CN110418803B (es)
AR (1) AR111083A1 (es)
AU (2) AU2018227502B2 (es)
BR (1) BR112019017755A2 (es)
CA (1) CA3051864A1 (es)
CL (1) CL2019002478A1 (es)
CO (1) CO2019009034A2 (es)
CR (1) CR20190400A (es)
EA (1) EA201991701A1 (es)
EC (1) ECSP19062769A (es)
GB (1) GB2564175B (es)
IL (2) IL312499A (es)
MX (1) MX2019010408A (es)
PH (1) PH12019501979A1 (es)
SG (1) SG11201906853QA (es)
TW (2) TWI761453B (es)
WO (1) WO2018160722A1 (es)
ZA (1) ZA202006797B (es)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT3094353T (pt) 2014-01-15 2020-06-08 Medimmune Llc Anticorpos específicos para o rsv e as suas partes funcionais
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
TWI761453B (zh) 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
JP7467438B2 (ja) 2018-10-18 2024-04-15 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｒｓｖ抗体の製剤及びその使用方法
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
EP3956351A1 (en) * 2019-04-18 2022-02-23 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Biological and synthetic molecules inhibiting respiratory syncytial virus infection
US12024553B2 (en) 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies
CN115960214A (zh) * 2021-10-12 2023-04-14 中国科学院分子细胞科学卓越创新中心 中和呼吸道合胞病毒的全人抗体的设计及应用
TW202342510A (zh) 2022-02-18 2023-11-01 英商Ｒｑ生物科技有限公司 抗體
CN116987183A (zh) * 2022-07-22 2023-11-03 北京智仁美博生物科技有限公司 抗呼吸道合胞病毒中和性抗体及其用途
WO2024120516A1 (zh) * 2022-12-08 2024-06-13 南京诺唯赞生物科技股份有限公司 特异性结合rsv的抗体

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5892019A (en) 1987-07-15 1999-04-06 The United States Of America, As Represented By The Department Of Health And Human Services Production of a single-gene-encoded immunoglobulin
US5811524A (en) 1995-06-07 1998-09-22 Idec Pharmaceuticals Corporation Neutralizing high affinity human monoclonal antibodies specific to RSV F-protein and methods for their manufacture and therapeutic use thereof
ES2148799T3 (es) 1995-09-18 2000-10-16 Intracel Corp Anticuerpos monoclonales neutralizantes contra virus sincitial respiratorio.
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
JP5290489B2 (ja) * 2001-11-08 2013-09-18 アッヴィ・バイオセラピューティクス・インコーポレイテッド Ｉｇｇ抗体の安定な液体医薬製剤
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
AU2013201261B2 (en) 2002-06-14 2016-06-23 Medimmune, Llc Stabilized liquid anti-RSV antibody formulations
CN1798575A (zh) * 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
TW200636064A (en) 2004-10-28 2006-10-16 Centocor Inc Anti-respiratory syncytial virus antibodies, antigens and uses thereof
WO2007103470A2 (en) * 2006-03-06 2007-09-13 Medimmune, Inc. Humanized anti-cd22 antibodies and their use in treatment of oncology, transplantation and autoimmune disease
EP1997830A1 (en) 2007-06-01 2008-12-03 AIMM Therapeutics B.V. RSV specific binding molecules and means for producing them
PE20091174A1 (es) * 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
WO2010053883A1 (en) 2008-11-05 2010-05-14 Merck Sharp & Dohme Corp. Live, attentuated respiratory syncytial virus
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
NZ599148A (en) 2009-10-06 2014-08-29 Medimmune Ltd Rsv-specific binding molecule
US8568726B2 (en) 2009-10-06 2013-10-29 Medimmune Limited RSV specific binding molecule
CL2011003002A1 (es) 2011-11-25 2012-05-25 Univ Pontificia Catolica Chile Anticuerpo monoclonal o un fragmento del mismo que se une a la proteina m2-1 del virus respiratorio sincicial (vrs) humano; secuencias nucleotidicas; composicion farmaceutica; metodo de diagnostico de infeccion producida por vrs; kit; y uso de dicho anticuerpo para preparar un medicamento.
BR122019026701B1 (pt) * 2012-03-26 2023-01-24 Sanofi Formulações de agentes de ligação à base de igg4 estáveis, kit, e dispositivo ou recipiente pré-cheios
US20140004131A1 (en) * 2012-05-04 2014-01-02 Novartis Ag Antibody formulation
US8883979B2 (en) * 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
CA2900110A1 (en) 2013-02-01 2014-08-07 Medimmune, Llc Respiratory syncytial virus f protein epitopes
PT3094353T (pt) 2014-01-15 2020-06-08 Medimmune Llc Anticorpos específicos para o rsv e as suas partes funcionais
CN107073113A (zh) * 2014-10-18 2017-08-18 辉瑞大药厂 抗il‑7r抗体组合物
EP3319633B1 (en) 2015-07-07 2020-11-11 Janssen Vaccines & Prevention B.V. Vaccine against rsv
JO3555B1 (ar) 2015-10-29 2020-07-05 Merck Sharp & Dohme جسم مضاد يبطل فعالية فيروس الالتهاب الرئوي البشري
TWI761453B (zh) * 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais

Also Published As

Publication number Publication date
ZA202006797B (en) 2023-03-29
US20230399383A1 (en) 2023-12-14
CA3051864A1 (en) 2018-09-07
KR20190125318A (ko) 2019-11-06
TW201840334A (zh) 2018-11-16
JP2020509031A (ja) 2020-03-26
KR102359181B1 (ko) 2022-02-08
IL268202A (en) 2019-09-26
KR20220020420A (ko) 2022-02-18
EP3589648A4 (en) 2020-12-23
US20210317191A1 (en) 2021-10-14
PH12019501979A1 (en) 2020-06-29
AR111083A1 (es) 2019-05-29
US10774133B2 (en) 2020-09-15
JP2022095697A (ja) 2022-06-28
GB2564175A (en) 2019-01-09
TW202228779A (zh) 2022-08-01
SG11201906853QA (en) 2019-09-27
US11667698B2 (en) 2023-06-06
EP3589648A1 (en) 2020-01-08
AU2022263564A1 (en) 2022-12-15
US20200339667A1 (en) 2020-10-29
CN117982637A (zh) 2024-05-07
IL268202B1 (en) 2024-06-01
MX2019010408A (es) 2019-12-19
WO2018160722A1 (en) 2018-09-07
EA201991701A1 (ru) 2020-03-04
IL312499A (en) 2024-07-01
TWI761453B (zh) 2022-04-21
BR112019017755A2 (pt) 2020-04-07
US11286294B2 (en) 2022-03-29
CO2019009034A2 (es) 2019-08-30
GB2564175B (en) 2021-12-08
CL2019002478A1 (es) 2020-01-24
CN116059343A (zh) 2023-05-05
CR20190400A (es) 2019-12-03
US20180251526A1 (en) 2018-09-06
AU2018227502B2 (en) 2022-08-11
JP7046088B2 (ja) 2022-04-01
GB201802974D0 (en) 2018-04-11
AU2018227502A1 (en) 2019-08-15
CN110418803B (zh) 2024-01-19
KR102668158B1 (ko) 2024-05-23
CN110418803A (zh) 2019-11-05
JP7446356B2 (ja) 2024-03-08

Similar Documents

Publication Publication Date Title
ECSP19062769A (es) Formulación de anticuerpo monoclonal anti-vrs
MX2019010282A (es) Formulacion de anticuerpos monoclonales.
AR108240A1 (es) Formulaciones que contienen anticuerpos
CY1126062T1 (el) Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1
CL2021000704A1 (es) Anticuerpos contra proteína alfa reguladora de señal y métodos de uso. (divisional de solicitud 668-2019)
AR122746A2 (es) Una formulación farmacéutica líquida estable de anticuerpo
CL2018000226A1 (es) Mezcla de péptidos (divisional solicitud 201601405)
NZ743964A (en) Aqueous pharmaceutical formulation comprising anti-pd-1 antibody avelumab
NZ719036A (en) Anti-pdl1 antibody formulations
BR112017003419A2 (pt) formulação de anticorpo anti-il-4r-alfa estável
CU20190015A7 (es) Formulaciones de anticuerpos inhibidores de masp-2 altamente concentrados, de baja viscosidad y composiciones farmacéuticas que las comprenden
CY1125697T1 (el) Σταθερες, υδατικες φαρμακοτεχνικες μορφες αντισωματων
MA53356B1 (fr) Formulations sous-cutanées d'anticorps anti-cd38 et leurs utilisations
CO2018003134A2 (es) Composiciones para el cuidado bucal que comprenden un aminoácido básico, una combinación de fuentes de iones de zinc y un sistema quelante
CL2012001966A1 (es) Formulación farmacéutica que comprende entre 100-150 mg/ml de un anticuerpo que se une específicamente al receptor a de il-17 humana, una solución acuosa de un buffer 5-30 mm de ácido glutámico ph 4,5-5,2, prolina 2-4% p/v y polisorbato-20 0,005-0,02% p/v; envase farmacéutico y kit que comprende dicha formulación; y su uso para tratar psoriasis.
GT201100181A (es) "inhibidores de proteina cinasa"
PE20191242A1 (es) Formulaciones de anticuerpo y metodos
PA8782201A1 (es) Anticuerpo humanizados contra el globulómero ab(20-42) y sus usos
BR112021017890A2 (pt) Composição líquida compreendendo um anticorpo do receptor alfa de interleucina-4 humana
PE20161032A1 (es) Anticuerpos anti-tau(ps422) humanizados y metodos de utilizacion
AR098168A1 (es) Formulación estable de insulina glulisina
CL2020002012A1 (es) Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas. (divisional solicitud 201903032)
MX2020004674A (es) Anticuerpos contra alfa-sinucleina y usos de los mismos.
PE20191476A1 (es) Nueva formulacion estable de anticuerpos anti-fxia
EA201992278A1 (ru) Способы и композиции для снижения иммуногенности