BR112019017755A2 - formulação de anticorpo monoclonal anti-rsv - Google Patents

formulação de anticorpo monoclonal anti-rsv Download PDF

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Publication number
BR112019017755A2
BR112019017755A2 BR112019017755-8A BR112019017755A BR112019017755A2 BR 112019017755 A2 BR112019017755 A2 BR 112019017755A2 BR 112019017755 A BR112019017755 A BR 112019017755A BR 112019017755 A2 BR112019017755 A2 BR 112019017755A2
Authority
BR
Brazil
Prior art keywords
formulation
monoclonal antibody
concentration
formulation according
present
Prior art date
Application number
BR112019017755-8A
Other languages
English (en)
Portuguese (pt)
Inventor
Lobo Brian
Goldberg Deborah
Original Assignee
Medimmune Limited
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 Medimmune Limited filed Critical Medimmune Limited
Publication of BR112019017755A2 publication Critical patent/BR112019017755A2/pt

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    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10RNA viruses
    • C07K16/102Coronaviridae (F)
    • C07K16/104Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10RNA viruses
    • C07K16/11Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
    • 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
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/522CH1 domain
    • 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
    • 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]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112019017755-8A 2017-03-01 2018-02-28 formulação de anticorpo monoclonal anti-rsv BR112019017755A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
US62/465,379 2017-03-01
PCT/US2018/020264 WO2018160722A1 (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Publications (1)

Publication Number Publication Date
BR112019017755A2 true BR112019017755A2 (pt) 2020-04-07

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019017755-8A BR112019017755A2 (pt) 2017-03-01 2018-02-28 formulação de anticorpo monoclonal anti-rsv

Country Status (24)

Country Link
US (4) US10774133B2 (https=)
EP (1) EP3589648A4 (https=)
JP (2) JP7046088B2 (https=)
KR (2) KR102668158B1 (https=)
CN (3) CN116059343A (https=)
AR (1) AR111083A1 (https=)
AU (2) AU2018227502B2 (https=)
BR (1) BR112019017755A2 (https=)
CA (1) CA3051864A1 (https=)
CL (1) CL2019002478A1 (https=)
CO (1) CO2019009034A2 (https=)
CR (1) CR20190400A (https=)
EA (1) EA201991701A1 (https=)
EC (1) ECSP19062769A (https=)
GB (1) GB2564175B (https=)
IL (2) IL268202B2 (https=)
MX (1) MX2019010408A (https=)
MY (1) MY206022A (https=)
PH (1) PH12019501979A1 (https=)
SG (1) SG11201906853QA (https=)
TW (2) TWI761453B (https=)
UA (1) UA128450C2 (https=)
WO (1) WO2018160722A1 (https=)
ZA (1) ZA202006797B (https=)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
EP4353316A3 (en) 2014-01-15 2024-08-21 Medimmune Limited Rsv-specific antibodies and functional parts thereof
JP2018535242A (ja) * 2015-11-30 2018-11-29 メディミューン,エルエルシー 高濃度のタンパク質ベースの治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比
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
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
AU2018263868A1 (en) 2017-05-02 2019-12-12 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
KR102885113B1 (ko) * 2018-10-18 2025-11-13 머크 샤프 앤드 돔 엘엘씨 항-rsv 항체의 제제 및 그의 사용 방법
CN120842406A (zh) 2018-10-31 2025-10-28 默沙东有限责任公司 抗人pd-1抗体晶体及其使用方法
CN113316458B (zh) 2018-11-07 2024-08-02 默沙东有限责任公司 抗lag3抗体和抗pd-1抗体的共制剂
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
US12534514B2 (en) * 2019-04-18 2026-01-27 Fraunhofer-Gesellschaft Zur Forderung Der Angewanditen Forschung 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
FI4045533T3 (fi) 2020-03-26 2024-02-02 Univ Vanderbilt Ihmisen monoklonaalisia vasta-aineita vakavalle akuutille koronavirus 2 -hengityselinoireyhtymälle (sars-cov-2)
WO2022026914A1 (en) * 2020-07-31 2022-02-03 Alamab Therapeutics, Inc. Anti-connexin antibody formulations
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
CN119264248A (zh) * 2022-07-22 2025-01-07 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 (29)

* 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
DE69609188T2 (de) 1995-09-18 2000-12-21 Intracel Corp., Issaquah Neutralisierende monoklonale antikörper gegen respiratorischen synzytialvirus
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
AU2013201261B2 (en) 2002-06-14 2016-06-23 Medimmune, Llc Stabilized liquid anti-RSV antibody formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
US7425618B2 (en) * 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (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
CA2644906C (en) * 2006-03-06 2016-05-10 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
CA2742086A1 (en) 2008-11-05 2010-05-14 Merck Sharp & Dohme Corp. Live, attenuated respiratory syncytial virus
US20120121580A1 (en) * 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
US8568726B2 (en) 2009-10-06 2013-10-29 Medimmune Limited RSV specific binding molecule
WO2011043643A1 (en) * 2009-10-06 2011-04-14 Medimmune Ltd 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.
JP6265970B2 (ja) * 2012-03-26 2018-01-24 サノフイ 安定なIgG4に基づく結合剤の製剤
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
LT2950886T (lt) 2013-02-01 2020-07-10 Medimmune, Llc Respiracinio sincitinio viruso f baltymo epitopai
EP4353316A3 (en) 2014-01-15 2024-08-21 Medimmune Limited Rsv-specific antibodies and functional parts thereof
KR20170065662A (ko) * 2014-10-18 2017-06-13 화이자 인코포레이티드 항-il-7r 항체 조성물
ES2839880T3 (es) 2015-07-07 2021-07-06 Janssen Vaccines & Prevention Bv Vacuna contra el VRS
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
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies

Also Published As

Publication number Publication date
CO2019009034A2 (es) 2019-08-30
EP3589648A4 (en) 2020-12-23
EA201991701A1 (ru) 2020-03-04
KR20220020420A (ko) 2022-02-18
US11286294B2 (en) 2022-03-29
AU2018227502A1 (en) 2019-08-15
JP7446356B2 (ja) 2024-03-08
AU2022263564B2 (en) 2025-05-22
JP2020509031A (ja) 2020-03-26
IL312499A (en) 2024-07-01
IL268202B2 (en) 2024-10-01
AU2022263564A1 (en) 2022-12-15
US20230399383A1 (en) 2023-12-14
IL268202B1 (en) 2024-06-01
GB201802974D0 (en) 2018-04-11
SG11201906853QA (en) 2019-09-27
CL2019002478A1 (es) 2020-01-24
CR20190400A (es) 2019-12-03
KR102359181B1 (ko) 2022-02-08
AU2018227502B2 (en) 2022-08-11
US10774133B2 (en) 2020-09-15
EP3589648A1 (en) 2020-01-08
AR111083A1 (es) 2019-05-29
JP2022095697A (ja) 2022-06-28
UA128450C2 (uk) 2024-07-17
ECSP19062769A (es) 2019-09-30
KR102668158B1 (ko) 2024-05-23
US20210317191A1 (en) 2021-10-14
MX2019010408A (es) 2019-12-19
GB2564175B (en) 2021-12-08
ZA202006797B (en) 2023-03-29
TW202228779A (zh) 2022-08-01
TWI911431B (zh) 2026-01-11
US11667698B2 (en) 2023-06-06
US20200339667A1 (en) 2020-10-29
IL268202A (en) 2019-09-26
TWI761453B (zh) 2022-04-21
CA3051864A1 (en) 2018-09-07
TW201840334A (zh) 2018-11-16
MY206022A (en) 2024-11-25
PH12019501979A1 (en) 2020-06-29
WO2018160722A1 (en) 2018-09-07
CN110418803B (zh) 2024-01-19
CN110418803A (zh) 2019-11-05
JP7046088B2 (ja) 2022-04-01
NZ755790A (en) 2024-04-26
CN116059343A (zh) 2023-05-05
KR20190125318A (ko) 2019-11-06
US20180251526A1 (en) 2018-09-06
CN117982637A (zh) 2024-05-07
GB2564175A (en) 2019-01-09

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Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI N? 10196/2001, QUE MODIFICOU A LEI N? 9279/96, A CONCESS?O DA PATENTE EST? CONDICIONADA ? ANU?NCIA PR?VIA DA ANVISA. CONSIDERANDO A APROVA??O DOS TERMOS DO PARECER N? 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL N? 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVID?NCIAS CAB?VEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
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