JP4948407B2 - 安定化処方 - Google Patents

安定化処方 Download PDF

Info

Publication number
JP4948407B2
JP4948407B2 JP2007525855A JP2007525855A JP4948407B2 JP 4948407 B2 JP4948407 B2 JP 4948407B2 JP 2007525855 A JP2007525855 A JP 2007525855A JP 2007525855 A JP2007525855 A JP 2007525855A JP 4948407 B2 JP4948407 B2 JP 4948407B2
Authority
JP
Japan
Prior art keywords
formulation
protein
antibody
results
nacl
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.)
Expired - Fee Related
Application number
JP2007525855A
Other languages
English (en)
Japanese (ja)
Other versions
JP2008515775A (ja
JP2008515775A5 (enExample
Inventor
リ・リ
アンジェラ・カントー
シャノン・ビー・マクミラン
Original Assignee
ワイス・エルエルシー
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 ワイス・エルエルシー filed Critical ワイス・エルエルシー
Publication of JP2008515775A publication Critical patent/JP2008515775A/ja
Publication of JP2008515775A5 publication Critical patent/JP2008515775A5/ja
Application granted granted Critical
Publication of JP4948407B2 publication Critical patent/JP4948407B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], 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

Landscapes

  • 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)
JP2007525855A 2004-08-13 2005-08-12 安定化処方 Expired - Fee Related JP4948407B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13
PCT/US2005/028861 WO2006020935A2 (en) 2004-08-13 2005-08-12 Stabilizing formulations

Publications (3)

Publication Number Publication Date
JP2008515775A JP2008515775A (ja) 2008-05-15
JP2008515775A5 JP2008515775A5 (enExample) 2011-11-10
JP4948407B2 true JP4948407B2 (ja) 2012-06-06

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2007525855A Expired - Fee Related JP4948407B2 (ja) 2004-08-13 2005-08-12 安定化処方

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)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
SMP200800064B (it) * 2006-04-21 2009-11-06 Novartis Ag Composizioni farmaceutiche di anticorpi anti-cd40 antagonista
CA2649538C (en) * 2006-04-21 2014-06-03 Yatin Gokarn 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
CA2681752A1 (en) 2007-03-29 2008-10-09 Abbott Laboratories Crystalline anti-human 1l-12 antibodies
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
MX2011005672A (es) * 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.
EP2403873A1 (en) 2009-03-05 2012-01-11 Ablynx N.V. Novel antigen binding dimer-complexes, methods of making/avoiding and uses thereof
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
US20100278822A1 (en) * 2009-05-04 2010-11-04 Abbott Biotechnology, Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
EP2473528B1 (en) 2009-09-03 2014-12-03 Ablynx N.V. Stable formulations of polypeptides and uses thereof
EA026226B1 (ru) * 2011-07-01 2017-03-31 Байоджен Айдек Ма Инк. Не содержащие аргинина композиции слитого fc-полипептида и способы их применения
AU2012345777B2 (en) 2011-11-30 2016-05-12 Kindeva Drug Delivery L.P. Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same
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
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
RU2016119491A (ru) 2013-11-04 2017-12-11 Пфайзер Инк. Конъюгаты антитела к efna4 с лекарственным средством
ES2939940T3 (es) 2014-03-28 2023-04-28 Univ Duke Tratamiento del cáncer de mama utilizando moduladores selectivos de los receptores de estrógenos
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
AU2015292822B2 (en) * 2014-07-21 2021-11-25 Unchained Labs Determination of protein aggregation from the concentration dependence of delta G
MX384605B (es) 2015-04-29 2025-03-14 Radius Pharmaceuticals Inc Combinación de palbociclib y rad1901 para usarse en el tratamiento de cáncer de mama en un sujeto con cáncer positivo a receptor de estrógeno.
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
EA201990316A1 (ru) 2016-08-18 2019-07-31 Ридженерон Фармасьютикалз, Инк. Анализ для определения потенциала самоассоциации белка с использованием концентрационно-зависимой спектроскопии самовзаимодействия на основе наночастиц
ES3064802T3 (en) 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
EP3565542B1 (en) 2017-01-05 2024-04-10 Radius Pharmaceuticals, Inc. Polymorphic forms of rad1901-2hcl
SG11202013177WA (en) 2018-07-04 2021-01-28 Radius Pharmaceuticals Inc Polymorphic forms of rad 1901-2hcl
US12441745B2 (en) 2019-02-12 2025-10-14 Radius Pharmaceuticals, Inc. Processes and compounds
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
WO2022154529A1 (ko) * 2021-01-14 2022-07-21 한올바이오파마주식회사 안정화제를 사용하지 않고도 안정한, 탄파너셉트를 포함하는 안과용 조성물
CN115541895B (zh) * 2022-11-29 2023-05-19 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

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3176517D1 (en) 1980-04-24 1987-12-17 Beecham Group Plc Beta-lactam compounds, their preparation and use
GB8518416D0 (en) 1985-07-22 1985-08-29 Beecham Group Plc Compounds
US5869053A (en) * 1988-03-04 1999-02-09 Cancer Research Campaign Technology, Ltd. 5T4 antigen from human trophoblasts
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6306393B1 (en) * 1997-03-24 2001-10-23 Immunomedics, Inc. Immunotherapy of B-cell malignancies using anti-CD22 antibodies
PT1012259E (pt) 1997-06-04 2009-11-06 Oxford Biomedica Ltd Vector dirigido a tumor
ATE230277T1 (de) * 1997-06-13 2003-01-15 Genentech Inc Stabilisierte antikörperformulierung
AU2444899A (en) 1998-01-22 1999-08-09 Astrazeneca Ab Pharmaceutical formulation comprising an antibody and a citrate buffer
JP4516711B2 (ja) * 1999-12-28 2010-08-04 中外製薬株式会社 安定な抗体組成物及び注射製剤
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
DE60139944D1 (de) * 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
NZ533657A (en) * 2002-01-03 2008-01-31 Smithkline Beecham Corp Methods for the preparation of immunoconjugates, in particular maytansinoids conjugated to a monoclonal antibody
BR122019027966B8 (pt) 2002-05-02 2021-07-27 Wyeth Corp conjugado monomérico de derivado de caliqueamicina/anti-corpo anti-cd22 e uso dos mesmos
AU2003251592A1 (en) * 2002-06-21 2004-01-06 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of use thereof
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP2007528868A (ja) * 2003-08-14 2007-10-18 ワイス 抗ルイスy抗イディオタイプ抗体およびその使用
CA2578131A1 (en) 2004-09-10 2006-03-23 Wyeth Humanized anti-5t4 antibodies and anti-5t4 antibody/calicheamicin conjugates

Also Published As

Publication number Publication date
EP1784219A2 (en) 2007-05-16
IL181265A0 (en) 2007-07-04
JP2008515775A (ja) 2008-05-15
US20060115472A1 (en) 2006-06-01
ECSP077246A (es) 2007-05-30
TW200621282A (en) 2006-07-01
WO2006020935A2 (en) 2006-02-23
MX2007001599A (es) 2007-04-10
US8871201B2 (en) 2014-10-28
BRPI0514340A (pt) 2008-06-10
CN101022831A (zh) 2007-08-22
NO20070930L (no) 2007-05-14
KR20070092197A (ko) 2007-09-12
CR8904A (es) 2007-08-28
RU2007109062A (ru) 2008-09-20
CA2575870A1 (en) 2006-02-23
EP1784219A4 (en) 2010-02-17
EP1784219B1 (en) 2017-05-17
ES2637854T3 (es) 2017-10-17
WO2006020935A3 (en) 2007-03-08
AR051009A1 (es) 2006-12-13
AU2005272603A1 (en) 2006-02-23

Similar Documents

Publication Publication Date Title
US8871201B2 (en) Stabilizing formulations
RU2731418C2 (ru) Стабильный фармацевтический препарат на основе антитела к pd-1 и его применение в медицине
ES2349779T5 (es) Formulaciones de anticuerpos y de proteínas a concentración elevada
JP4091087B2 (ja) 抗体精製
CN100353997C (zh) 稳定的含蛋白质的制剂
ES3063234T3 (en) Formulations of anti-pd1 antibodies
TWI825297B (zh) 抗Her2 抗體藥物偶聯物藥物製劑
JPH0565233A (ja) モノクローナル抗体含有凍結乾燥製剤
JP2005513110A (ja) Egf受容体に対する抗体を含む凍結乾燥製剤
TW201028167A (en) Pharmaceutical composition
JP2021178862A (ja) タンパク質製剤
WO1989011298A1 (en) Formulation for antibody reagents
JP2026048681A (ja) 安定した抗pd-1抗体薬剤学的製剤
WO2019085982A1 (zh) 一种抗pd-l1人源化单克隆抗体的药物组合物
JP2023506629A (ja) 安定した抗pd-1抗体の薬剤学的製剤
TW201534349A (zh) TNFR:Fc融合多肽之替代調配物
CN114504642B (zh) 一种含抗cldn18.2抗体的液体药物组合物
Chang et al. Physical stability of protein pharmaceuticals
JP2025023952A (ja) 液体タンパク質製剤を安定化するための組成物及び方法
JPWO2008029908A1 (ja) 抗体を含有する安定な凍結乾燥医薬製剤
KR20240046687A (ko) 염증성 및 자가면역 질환 치료용 이온성 액체 제제
WO2022117795A1 (en) Novel formulations for antibodies
WO2021141789A1 (en) Stable formulations of anti-cancer peptides
WO2023122691A1 (en) Complement factor-i formulations
CN117323430A (zh) 抗pcsk9抗体的制剂及其应用

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20080623

RD03 Notification of appointment of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7423

Effective date: 20110117

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20110128

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20110322

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110613

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110620

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110712

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110720

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110819

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110826

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20110922

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20111017

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20120116

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120119

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20120123

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20120213

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20120306

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20150316

Year of fee payment: 3

R150 Certificate of patent or registration of utility model

Ref document number: 4948407

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees