CN101022831A - 稳定制剂 - Google Patents

稳定制剂 Download PDF

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Publication number
CN101022831A
CN101022831A CNA2005800274833A CN200580027483A CN101022831A CN 101022831 A CN101022831 A CN 101022831A CN A2005800274833 A CNA2005800274833 A CN A2005800274833A CN 200580027483 A CN200580027483 A CN 200580027483A CN 101022831 A CN101022831 A CN 101022831A
Authority
CN
China
Prior art keywords
protein
formulation
molecular weight
antibody
stability
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
CNA2005800274833A
Other languages
English (en)
Chinese (zh)
Inventor
L·李
A·坎托尔
S·B·麦米兰
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.)
Wyeth LLC
Original Assignee
Wyeth LLC
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 Wyeth LLC filed Critical Wyeth LLC
Publication of CN101022831A publication Critical patent/CN101022831A/zh
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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
CNA2005800274833A 2004-08-13 2005-08-12 稳定制剂 Pending CN101022831A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13

Publications (1)

Publication Number Publication Date
CN101022831A true CN101022831A (zh) 2007-08-22

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA2005800274833A Pending CN101022831A (zh) 2004-08-13 2005-08-12 稳定制剂

Country Status (18)

Country Link
US (1) US8871201B2 (enExample)
EP (1) EP1784219B1 (enExample)
JP (1) JP4948407B2 (enExample)
KR (1) KR20070092197A (enExample)
CN (1) CN101022831A (enExample)
AR (1) AR051009A1 (enExample)
AU (1) AU2005272603A1 (enExample)
BR (1) BRPI0514340A (enExample)
CA (1) CA2575870A1 (enExample)
CR (1) CR8904A (enExample)
EC (1) ECSP077246A (enExample)
ES (1) ES2637854T3 (enExample)
IL (1) IL181265A0 (enExample)
MX (1) MX2007001599A (enExample)
NO (1) NO20070930L (enExample)
RU (1) RU2007109062A (enExample)
TW (1) TW200621282A (enExample)
WO (1) WO2006020935A2 (enExample)

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CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

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EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
GEP20125628B (en) * 2006-04-21 2012-09-10 Novartis Ag Pharmaceutical compositions containing antagonist anti-cd40 antibody
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
US20080070230A1 (en) * 2006-06-12 2008-03-20 Wyeth Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions
EP1950225A1 (de) * 2007-01-25 2008-07-30 Octapharma AG Verfahren zur Steigerung von Proteinausbeuten
EP2527364A1 (en) * 2007-03-29 2012-11-28 Abbott Laboratories Crystalline anti-human IL-12 antibodies
TWI661833B (zh) * 2007-11-30 2019-06-11 百慕達商艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
CN104398471A (zh) * 2008-11-28 2015-03-11 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
US10005830B2 (en) 2009-03-05 2018-06-26 Ablynx N.V. Antigen binding dimer-complexes, methods of making/avoiding and uses thereof
NZ613809A (en) * 2009-05-04 2015-02-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
PT2473528E (pt) 2009-09-03 2015-03-04 Ablynx NV Formulações estáveis de polipéptidos e seus usos
WO2013006454A1 (en) 2011-07-01 2013-01-10 Biogen Idec Ma Inc. Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use
AU2012345768B2 (en) 2011-11-30 2016-05-12 Kindeva Drug Delivery L.P. Microneedle device having a peptide therapeutic agent and an amino acid, methods of making and using the same
CA3204402A1 (en) * 2012-03-26 2013-10-03 Sanofi Stable anti-cxcr5 igg4 antibody formulations
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody
EP3065780A1 (en) 2013-11-04 2016-09-14 Pfizer Inc. Anti-efna4 antibody-drug conjugates
PT3122426T (pt) 2014-03-28 2023-02-28 Univ Duke Tratamento de cancro da mama utilizando moduladores seletivos do recetor de estrogénio
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
EP3288383A4 (en) 2015-04-29 2019-01-23 Radius Pharmaceuticals, Inc. METHOD FOR THE TREATMENT OF CANCER
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
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AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
ES2981967T3 (es) 2017-01-05 2024-10-14 Radius Pharmaceuticals Inc Formas polimórficas de RAD1901-2HCl
JP7473486B2 (ja) 2018-07-04 2024-04-23 ラジウス ファーマシューティカルズ，インコーポレイテッド Ｒａｄ１９０１－２ｈｃｌの多形形態
JOP20210218A1 (ar) 2019-02-12 2023-01-30 Radius Pharmaceuticals Inc عمليات ومركبات
US20230167153A1 (en) * 2020-05-01 2023-06-01 Kashiv Biosciences, Llc An improved process of purification of protein
JP2024503462A (ja) * 2021-01-14 2024-01-25 ハノル バイオファーマ カンパニーリミテッド 安定化剤を使用せずに安定した、タンパーナセプトを含む眼科用組成物

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Cited By (6)

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CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11428695B2 (en) 2016-08-18 2022-08-30 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN109661577B (zh) * 2016-08-18 2022-09-27 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11988668B2 (en) 2016-08-18 2024-05-21 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

Also Published As

Publication number Publication date
EP1784219A4 (en) 2010-02-17
ES2637854T3 (es) 2017-10-17
JP2008515775A (ja) 2008-05-15
US20060115472A1 (en) 2006-06-01
RU2007109062A (ru) 2008-09-20
EP1784219A2 (en) 2007-05-16
KR20070092197A (ko) 2007-09-12
CR8904A (es) 2007-08-28
NO20070930L (no) 2007-05-14
AR051009A1 (es) 2006-12-13
CA2575870A1 (en) 2006-02-23
AU2005272603A1 (en) 2006-02-23
JP4948407B2 (ja) 2012-06-06
EP1784219B1 (en) 2017-05-17
WO2006020935A2 (en) 2006-02-23
TW200621282A (en) 2006-07-01
US8871201B2 (en) 2014-10-28
BRPI0514340A (pt) 2008-06-10
IL181265A0 (en) 2007-07-04
WO2006020935A3 (en) 2007-03-08
ECSP077246A (es) 2007-05-30
MX2007001599A (es) 2007-04-10

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C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Open date: 20070822