JP4937358B2 - 高濃度抗体含有溶液製剤 - Google Patents
高濃度抗体含有溶液製剤 Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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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
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- 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
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- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
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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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
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- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- Bioinformatics & Cheminformatics (AREA)
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- Proteomics, Peptides & Aminoacids (AREA)
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- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Description
(1)アルギニン及びメチオニンを含有することを特徴とする、安定な抗体含有溶液製剤。
(2)さらにヒスチジン緩衝剤を含む、(1)に記載の溶液製剤。
(3)さらに界面活性剤を含む、(1)または(2)に記載の溶液製剤。
(4)抗体の濃度が50mg/ml以上である、(1)〜(3)に記載の溶液製剤。
(5)抗体の濃度が100mg/ml以上である、(1)〜(3)に記載の溶液製剤。
(6)抗体の濃度が120mg/ml以上である、(1)〜(3)に記載の溶液製剤。
(7)抗体が抗インターロイキン−6レセプター抗体である、(1)〜(6)に記載の溶液製剤。
(8)アルギニンまたはメチオニンを含有することを特徴とする、安定な抗インターロイキン−6レセプター抗体含有溶液製剤。
(9)抗体がヒト化抗体またはヒト抗体である、(1)〜(8)に記載の溶液製剤。
(10)さらにトリプトファンを含む、(1)〜(9)に記載の溶液製剤。
(11)pHが4〜8である、(1)〜(10)に記載の溶液製剤。
(12)アルギニンの含有量が、50〜1500mMである、(1)〜(11)に記載の溶液製剤。
(13)粘度が、2〜15mPa・sである、(1)〜(12)に記載の溶液製剤。
(14)溶液製剤が22〜28℃で少なくとも6ヶ月間安定である、(1)〜(13)に記載の溶液製剤。
(15)抗体二量体の生成が抑制されることを特徴とする、(1)〜(13)に記載の溶液製剤。
(16)抗体分子の脱アミド化が抑制されることを特徴とする、(1)〜(13)に記載の溶液製剤。
(17)皮下投与される、(1)〜(13)に記載の溶液製剤。
(18)溶液製剤の製造過程に凍結乾燥工程を含まないで製造される、(1)〜(13)に記載の溶液製剤。
(19)溶液中にアルギニンを添加することを含む,抗体含有溶液製剤の抗体分子の脱アミド化を抑制する方法。
(20)溶液中にアルギニンとメチオニンを添加することを含む,抗体含有溶液製剤の抗体二量体生成を抑制する方法。
できる。
A)抗IL−6レセプター抗体
B)アルギニンおよび/またはメチオニン、および任意の追加成分としてさらに別のアミノ酸(例えばトリプトファン)
C)緩衝剤、及び
D)界面活性剤
から実質的に構成される。
抗体試料
抗IL−6レセプターヒト化抗体は国際特許出願公開番号WO92/19759号公報の実施例10に記載されたヒトエロンゲーションファクターIαプロモーターを利用し、特開平8−99902号公報の参考例2に記載された方法に準じて作成したヒト化抗体である。なお、実施例の表中ではMRAと記載することもある。
抗IL-6レセプターヒト化抗体を含む溶液製剤について、アルギニンとメチオニンの組合せが製剤の安定化に及ぼす影響を評価した。
[ゲルろ過クロマトグラフ法]
試料をそのまま測定溶液とする。
抗IL-6レセプターヒト化抗体を含む溶液製剤について、アルギニンによる脱アミド化の抑制効果を評価した。
[イオン交換クロマトグラフ法]
試料に精製水を加えて1mL中に抗IL-6レセプターヒト化抗体を約1mg 相当量含む液を調製したものを各試料の測定溶液とする。
実施例1と同様に抗IL-6レセプターヒト化抗体を含む溶液製剤について、アルギニンとメチオニンの組合せが製剤の安定化に及ぼす影響を評価した。
Claims (2)
- ヒト化抗インターロイキン−6レセプター抗体MRAを含有する安定な溶液製剤であって、該抗体180mg/ml、アルギニン100mM、メチオニン10〜50mM、および0.005〜3%(w/v)のポリソルベート80を、pH4〜8、5〜100mMのヒスチジン緩衝液中に含有することを特徴とする、前記製剤。
- ヒト化抗インターロイキン−6レセプター抗体MRAを含有する溶液製剤において該抗体二量体の生成を抑制する方法であって、溶液中にアルギニンとメチオニンを添加することを含み、溶液中のアルギニン濃度が100mM、メチオニン濃度が10〜50mM、抗体濃度が180mg/ml、溶液のpHが4〜8、ヒスチジン緩衝液濃度が5〜100mM、ポリソルベート80の濃度が0.005〜3%(w/v)とすることを特徴とする、前記方法。
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JP2009548102A JP4937358B2 (ja) | 2007-12-27 | 2008-12-26 | 高濃度抗体含有溶液製剤 |
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JP2007336310 | 2007-12-27 | ||
JP2007336310 | 2007-12-27 | ||
PCT/JP2008/073798 WO2009084659A1 (ja) | 2007-12-27 | 2008-12-26 | 高濃度抗体含有溶液製剤 |
JP2009548102A JP4937358B2 (ja) | 2007-12-27 | 2008-12-26 | 高濃度抗体含有溶液製剤 |
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JPWO2009084659A1 JPWO2009084659A1 (ja) | 2011-05-19 |
JP4937358B2 true JP4937358B2 (ja) | 2012-05-23 |
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JP2009548102A Active JP4937358B2 (ja) | 2007-12-27 | 2008-12-26 | 高濃度抗体含有溶液製剤 |
JP2011257255A Active JP5906067B2 (ja) | 2007-12-27 | 2011-11-25 | 高濃度抗体含有溶液製剤 |
JP2015223070A Active JP6259436B2 (ja) | 2007-12-27 | 2015-11-13 | 高濃度抗体含有溶液製剤 |
JP2017234971A Active JP6567024B2 (ja) | 2007-12-27 | 2017-12-07 | 高濃度抗体含有溶液製剤 |
JP2019139465A Pending JP2019206559A (ja) | 2007-12-27 | 2019-07-30 | 高濃度抗体含有溶液製剤 |
JP2021109852A Active JP7256234B2 (ja) | 2007-12-27 | 2021-07-01 | 高濃度抗体含有溶液製剤 |
JP2023009289A Pending JP2023055780A (ja) | 2007-12-27 | 2023-01-25 | 高濃度抗体含有溶液製剤 |
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JP2011257255A Active JP5906067B2 (ja) | 2007-12-27 | 2011-11-25 | 高濃度抗体含有溶液製剤 |
JP2015223070A Active JP6259436B2 (ja) | 2007-12-27 | 2015-11-13 | 高濃度抗体含有溶液製剤 |
JP2017234971A Active JP6567024B2 (ja) | 2007-12-27 | 2017-12-07 | 高濃度抗体含有溶液製剤 |
JP2019139465A Pending JP2019206559A (ja) | 2007-12-27 | 2019-07-30 | 高濃度抗体含有溶液製剤 |
JP2021109852A Active JP7256234B2 (ja) | 2007-12-27 | 2021-07-01 | 高濃度抗体含有溶液製剤 |
JP2023009289A Pending JP2023055780A (ja) | 2007-12-27 | 2023-01-25 | 高濃度抗体含有溶液製剤 |
Country Status (31)
Country | Link |
---|---|
US (8) | US8568720B2 (ja) |
EP (1) | EP2238985B2 (ja) |
JP (7) | JP4937358B2 (ja) |
KR (1) | KR101083616B1 (ja) |
CN (2) | CN106075434B (ja) |
AR (2) | AR069969A1 (ja) |
AU (1) | AU2008344292B2 (ja) |
BR (1) | BRPI0818903B8 (ja) |
CA (1) | CA2708627C (ja) |
CL (1) | CL2008003910A1 (ja) |
CO (1) | CO6450630A2 (ja) |
CR (1) | CR11594A (ja) |
CY (1) | CY1113616T1 (ja) |
DK (1) | DK2238985T4 (ja) |
EC (1) | ECSP10010370A (ja) |
ES (1) | ES2389881T5 (ja) |
HR (1) | HRP20120903T4 (ja) |
IL (2) | IL206548A (ja) |
MA (1) | MA31934B1 (ja) |
MX (1) | MX2010004399A (ja) |
MY (1) | MY159450A (ja) |
NZ (1) | NZ586378A (ja) |
PE (1) | PE20091174A1 (ja) |
PL (1) | PL2238985T5 (ja) |
PT (1) | PT2238985E (ja) |
RU (2) | RU2497544C2 (ja) |
SG (1) | SG2013049325A (ja) |
SI (1) | SI2238985T2 (ja) |
TW (1) | TWI375566B (ja) |
UA (1) | UA104134C2 (ja) |
WO (1) | WO2009084659A1 (ja) |
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UA80091C2 (en) | 2001-04-02 | 2007-08-27 | Chugai Pharmaceutical Co Ltd | Remedies for infant chronic arthritis-relating diseases and still's disease which contain an interleukin-6 (il-6) antagonist |
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RU2609658C2 (ru) | 2009-12-21 | 2017-02-02 | Дженентек, Инк. | Состав, содержащий антитело |
JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
MX366337B (es) * | 2010-10-06 | 2019-07-05 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-receptor de interleucina-4 (il-4r). |
EP4029881A1 (en) | 2010-11-08 | 2022-07-20 | F. Hoffmann-La Roche AG | Subcutaneously administered anti-il-6 receptor antibody |
MX355060B (es) | 2010-11-17 | 2018-04-03 | Chugai Pharmaceutical Co Ltd | Molecula multiespecifica de union a antigeno que tiene funcion alternativa a la funcion del factor viii de coagulacion sanguinea. |
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