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BR112023000216A2 - Preparação de seringa pré-carregada com agulha, com proteção de agulha e incluindo anticorpo modificado - Google Patents

Preparação de seringa pré-carregada com agulha, com proteção de agulha e incluindo anticorpo modificado

Info

Publication number
BR112023000216A2
BR112023000216A2 BR112023000216A BR112023000216A BR112023000216A2 BR 112023000216 A2 BR112023000216 A2 BR 112023000216A2 BR 112023000216 A BR112023000216 A BR 112023000216A BR 112023000216 A BR112023000216 A BR 112023000216A BR 112023000216 A2 BR112023000216 A2 BR 112023000216A2
Authority
BR
Brazil
Prior art keywords
needle
filled syringe
syringe preparation
modified antibody
including modified
Prior art date
Application number
BR112023000216A
Other languages
English (en)
Inventor
Fukuda Masakazu
YAMASHITA Shogo
Yamanaka Yuji
Mueller Robert
Yang Kewei
Original Assignee
Chugai Pharmaceutical Co Ltd
Hoffmann La Roche
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 Chugai Pharmaceutical Co Ltd, Hoffmann La Roche filed Critical Chugai Pharmaceutical Co Ltd
Publication of BR112023000216A2 publication Critical patent/BR112023000216A2/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Vascular Medicine (AREA)
  • Mycology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Peptides Or Proteins (AREA)

Abstract

PREPARAÇÃO DE SERINGA PRÉ-CARREGADA COM AGULHA, COM PROTEÇÃO DE AGULHA E INCLUINDO ANTICORPO MODIFICADO. A presente invenção refere-se ao fornecimento de preparação de seringa pré-carregada com uma agulha, contendo anticorpos modificados por uma mutação para histidina, o que reduz o risco de bloqueio da agulha ou de dificuldades na extrusão de fármacos. A formulação de seringa pré-carregada com uma agulha permite a fabricação em escala industrial por um método simples. Esta preparação de seringa pré-carregada caracteriza-se por ser fornecida com uma proteção de agulha de elastômero com baixa eluição de zinco.
BR112023000216A 2020-07-28 2021-07-27 Preparação de seringa pré-carregada com agulha, com proteção de agulha e incluindo anticorpo modificado BR112023000216A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020127605 2020-07-28
PCT/JP2021/027663 WO2022025030A1 (ja) 2020-07-28 2021-07-27 新規改変型抗体を含む、針シールドを備えた針付プレフィルドシリンジ製剤

Publications (1)

Publication Number Publication Date
BR112023000216A2 true BR112023000216A2 (pt) 2023-02-07

Family

ID=80036593

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023000216A BR112023000216A2 (pt) 2020-07-28 2021-07-27 Preparação de seringa pré-carregada com agulha, com proteção de agulha e incluindo anticorpo modificado

Country Status (11)

Country Link
EP (1) EP4190354A1 (pt)
JP (1) JPWO2022025030A1 (pt)
KR (1) KR20230047397A (pt)
CN (1) CN116194473A (pt)
AU (1) AU2021315210A1 (pt)
BR (1) BR112023000216A2 (pt)
CA (1) CA3186914A1 (pt)
IL (1) IL300182A (pt)
MX (1) MX2023000854A (pt)
TW (1) TW202220694A (pt)
WO (1) WO2022025030A1 (pt)

Family Cites Families (27)

* Cited by examiner, † Cited by third party
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JPS58201994A (ja) 1982-05-21 1983-11-25 Hideaki Hagiwara 抗原特異的ヒト免疫グロブリンの生産方法
GB8607679D0 (en) 1986-03-27 1986-04-30 Winter G P Recombinant dna product
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
DK0585287T3 (da) 1990-07-10 2000-04-17 Cambridge Antibody Tech Fremgangsmåde til fremstilling af specifikke bindingsparelementer
WO1993012227A1 (en) 1991-12-17 1993-06-24 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
DK0546073T3 (da) 1990-08-29 1998-02-02 Genpharm Int Frembringelse og anvendelse af transgene, ikke-humane dyr, der er i stand til at danne heterologe antistoffer
WO1994025585A1 (en) 1993-04-26 1994-11-10 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
JP3540315B2 (ja) 1991-09-23 2004-07-07 メディカル リサーチ カウンシル キメラ抗体の製造−組合せアプローチ
ES2227512T3 (es) 1991-12-02 2005-04-01 Medical Research Council Produccion de anticuerpos contra auto-antigenos a partir de repertorios de segmentos de anticuerpos fijados en un fago.
EP0656941B1 (en) 1992-03-24 2005-06-01 Cambridge Antibody Technology Limited Methods for producing members of specific binding pairs
SG48760A1 (en) 1992-07-24 2003-03-18 Abgenix Inc Generation of xenogenetic antibodies
GB9313509D0 (en) 1993-06-30 1993-08-11 Medical Res Council Chemisynthetic libraries
CA2177367A1 (en) 1993-12-03 1995-06-08 Andrew David Griffiths Recombinant binding proteins and peptides
HU221385B1 (en) 1994-07-13 2002-09-28 Chugai Pharmaceutical Co Ltd Reconstituted human antibody against human interleukin-8
AU5632296A (en) 1995-04-27 1996-11-18 Abgenix, Inc. Human antibodies derived from immunized xenomice
AU2466895A (en) 1995-04-28 1996-11-18 Abgenix, Inc. Human antibodies derived from immunized xenomice
CN101939425B (zh) 2007-09-26 2014-05-14 中外制药株式会社 抗il-6受体抗体
MX342551B (es) 2007-09-26 2016-10-04 Chugai Pharmaceutical Co Ltd Region constante de anticuerpo modificada.
EP3127921A1 (en) 2007-09-26 2017-02-08 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substition in cdr
TWI418363B (zh) 2007-09-28 2013-12-11 Chugai Pharmaceutical Co Ltd 血漿中動態經改善之磷脂醯肌醇蛋白聚醣３抗體
BRPI0821110B8 (pt) 2007-12-05 2021-05-25 Chugai Pharmaceutical Co Ltd anticorpo de neutralização de anti-nr10/il31ra, composição farmacêutica compreendendo o referido anticorpo e uso do mesmo
TR201808535T4 (tr) 2008-04-11 2018-07-23 Chugai Pharmaceutical Co Ltd İki veya daha fazla sayıda antijen molekülüne tekrar tekrar bağlanabilen antijen bağlanma molekülü.
WO2016066821A1 (en) 2014-10-30 2016-05-06 F. Hoffmann-La Roche Ag Syringe and method of preparing a syringe
TWI741969B (zh) 2014-10-30 2021-10-11 日商中外製藥股份有限公司 具備注射器蓋之附針預填充注射器製劑
KR101674438B1 (ko) 2014-12-05 2016-11-09 이승한 프로젝트 발주 및 프로젝트의 컴포넌트 개발을 위한 플랫폼 운영 시스템 및 그 방법
WO2017038463A1 (ja) 2015-08-31 2017-03-09 ソニー株式会社 送信装置、および送信方法、情報処理装置、および情報処理方法、並びにプログラム
PE20181336A1 (es) * 2015-09-18 2018-08-21 Chugai Pharmaceutical Co Ltd Anticuerpos que se unen a interleucina 8 (il-8) y sus usos

Also Published As

Publication number Publication date
MX2023000854A (es) 2023-02-15
AU2021315210A1 (en) 2023-03-09
CA3186914A1 (en) 2022-02-03
IL300182A (en) 2023-03-01
KR20230047397A (ko) 2023-04-07
JPWO2022025030A1 (pt) 2022-02-03
CN116194473A (zh) 2023-05-30
EP4190354A1 (en) 2023-06-07
TW202220694A (zh) 2022-06-01
WO2022025030A1 (ja) 2022-02-03

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