JP2010529999A - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP2010529999A
JP2010529999A JP2010512385A JP2010512385A JP2010529999A JP 2010529999 A JP2010529999 A JP 2010529999A JP 2010512385 A JP2010512385 A JP 2010512385A JP 2010512385 A JP2010512385 A JP 2010512385A JP 2010529999 A JP2010529999 A JP 2010529999A
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JP
Japan
Prior art keywords
composition
antibody
vla
patient
unit dose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2010512385A
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English (en)
Japanese (ja)
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JP2010529999A5 (enExample
Inventor
マロネイ ケビン
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biogen Inc
Biogen MA Inc
Original Assignee
Biogen Inc
Biogen Idec Inc
Biogen Idec MA Inc
Biogen MA 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 Biogen Inc, Biogen Idec Inc, Biogen Idec MA Inc, Biogen MA Inc filed Critical Biogen Inc
Publication of JP2010529999A publication Critical patent/JP2010529999A/ja
Publication of JP2010529999A5 publication Critical patent/JP2010529999A5/ja
Pending legal-status Critical Current

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    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
JP2010512385A 2007-06-14 2008-06-13 抗体製剤 Pending JP2010529999A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US94407607P 2007-06-14 2007-06-14
PCT/US2008/066928 WO2008157356A2 (en) 2007-06-14 2008-06-13 Antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2013182749A Division JP2014040424A (ja) 2007-06-14 2013-09-04 抗体製剤

Publications (2)

Publication Number Publication Date
JP2010529999A true JP2010529999A (ja) 2010-09-02
JP2010529999A5 JP2010529999A5 (enExample) 2011-07-28

Family

ID=39956053

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2010512385A Pending JP2010529999A (ja) 2007-06-14 2008-06-13 抗体製剤
JP2013182749A Pending JP2014040424A (ja) 2007-06-14 2013-09-04 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2013182749A Pending JP2014040424A (ja) 2007-06-14 2013-09-04 抗体製剤

Country Status (24)

Country Link
US (3) US20080311119A1 (enExample)
EP (2) EP2170390B1 (enExample)
JP (2) JP2010529999A (enExample)
CN (2) CN103977404A (enExample)
AR (2) AR067011A1 (enExample)
AU (1) AU2008266051B2 (enExample)
BR (1) BRPI0814252B8 (enExample)
CA (1) CA2690382A1 (enExample)
CY (1) CY1121208T1 (enExample)
DK (1) DK2170390T3 (enExample)
EA (1) EA020456B1 (enExample)
ES (1) ES2707815T3 (enExample)
HR (1) HRP20182146T1 (enExample)
HU (1) HUE041555T2 (enExample)
IL (1) IL202648B (enExample)
LT (1) LT2170390T (enExample)
MX (2) MX2009013593A (enExample)
NZ (2) NZ595526A (enExample)
PL (1) PL2170390T3 (enExample)
PT (1) PT2170390T (enExample)
SI (1) SI2170390T1 (enExample)
TR (1) TR201820837T4 (enExample)
TW (1) TWI614028B (enExample)
WO (1) WO2008157356A2 (enExample)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014530863A (ja) * 2011-10-18 2014-11-20 コヒラス・バイオサイエンシズ・インコーポレイテッド キシリトールによって安定化されたエタネルセプト製剤
JP2017502922A (ja) * 2013-10-29 2017-01-26 アルブミディクス アクティーゼルスカブ 抗体組成物
JP2017520531A (ja) * 2014-06-02 2017-07-27 ラボラトワール フランセ デュ フラクショヌマン エ デ ビオテクノロジーＬａｂｏｒａｔｏｉｒｅ Ｆｒａｎｃａｉｓ ｄｕ Ｆｒａｃｔｉｏｎｎｅｍｅｎｔ ｅｔ ｄｅｓ Ｂｉｏｔｅｃｈｎｏｌｏｇｉｅｓ Ｆｃ断片の産生
JP2018138614A (ja) * 2012-02-16 2018-09-06 サンタラス， インコーポレイテッド 抗ｖｌａ１（ｃｄ４９ａ）抗体医薬組成物
US10485869B2 (en) 2011-10-18 2019-11-26 Coherus Biosciences, Inc. Etanercept formulations stabilized with meglumine
JP2020511443A (ja) * 2017-03-06 2020-04-16 アレコル リミテッド 液体医薬組成物
US10822429B2 (en) 2012-07-09 2020-11-03 Coherus Biosciences, Inc. Etanercept formulations exhibiting marked reduction in sub-visible particles
US10947306B2 (en) 2012-09-11 2021-03-16 Coherus Biosciences, Inc. Correctly folded etanercept in high purity and excellent yield
JP2021528957A (ja) * 2018-06-28 2021-10-28 アレクシオン ファーマシューティカルズ， インコーポレイテッド 抗ｃ５抗体の産生方法
JPWO2022092183A1 (enExample) * 2020-10-30 2022-05-05
JP2022546400A (ja) * 2019-08-30 2022-11-04 カシーヴ バイオサイエンシズ，リミテッド・ライアビリティ・カンパニー 高濃度の薬理学的に活性な抗体の新規製剤
JP2023071755A (ja) * 2017-02-24 2023-05-23 アレコル リミテッド 安定化された抗体溶液
US12128101B2 (en) 2017-10-26 2024-10-29 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
US12459992B2 (en) 2016-05-27 2025-11-04 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis

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EP3777880A1 (en) 2003-02-10 2021-02-17 Biogen MA Inc. Immunoglobulin formulation and method of preparation thereof
EP2453874A2 (en) * 2009-07-14 2012-05-23 Biogen Idec MA Inc. Methods for inhibiting yellow color and peroxide formation in a composition
CA2789061A1 (en) 2010-02-26 2011-09-01 Henrik Parshad Stable antibody containing compositions
LT3345615T (lt) 2010-03-01 2020-02-10 Bayer Healthcare Llc Optimizuoti monokloniniai antikūnai prieš audinių faktoriaus kelio slopiklį (tfpi)
PT3202789T (pt) 2010-04-16 2020-06-16 Biogen Ma Inc Anticorpos anti-vla-4
RS66182B1 (sr) 2010-05-28 2024-12-31 Novo Nordisk As Stabilne višedozne kompozicije koje sadrže antitelo i konzervans
WO2013006461A1 (en) * 2011-07-01 2013-01-10 Biogen Idec Ma Inc. Cholesterol-based media supplementals for cell culture
CN104520326A (zh) * 2012-06-21 2015-04-15 Ucb医药有限公司 药物制剂
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
CN103217525B (zh) * 2013-03-21 2015-04-29 上海执诚生物科技股份有限公司 一种含有提高胱抑素c胶乳包被抗体的稳定性的组合物、稳定剂及其制备方法和用途
KR102362002B1 (ko) * 2013-11-29 2022-02-10 제넨테크, 인크. 항체 선택 장치 및 방법
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JP2017510627A (ja) * 2014-03-13 2017-04-13 プロセナ バイオサイエンシーズ リミテッド 多発性硬化症の併用治療
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JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
CN112292146A (zh) * 2018-04-10 2021-01-29 雷迪博士实验室有限公司 治疗性抗体的稳定的制剂
WO2019236417A1 (en) 2018-06-04 2019-12-12 Biogen Ma Inc. Anti-vla-4 antibodies having reduced effector function
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
WO2021007504A2 (en) * 2019-07-10 2021-01-14 Regeneron Pharmaceuticals, Inc. Methods and compositions comprising reduced level of host cell proteins
CN113134081A (zh) * 2020-01-20 2021-07-20 上海君实生物医药科技股份有限公司 抗btla抗体药物组合物及其用途
KR20230107644A (ko) 2020-11-14 2023-07-17 바이오젠 엠에이 인코포레이티드 항-vla-4 항체에 대한 2상 피하 투여 요법
EP4323407A1 (en) 2021-04-13 2024-02-21 Biogen MA Inc. Compositions and methods for treating chronic active white matter lesions / radiologically isolated syndrome

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Cited By (32)

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