CN101172100A - 稳定等渗的冻干蛋白质制剂 - Google Patents

稳定等渗的冻干蛋白质制剂 Download PDF

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Publication number
CN101172100A
CN101172100A CNA2007101928120A CN200710192812A CN101172100A CN 101172100 A CN101172100 A CN 101172100A CN A2007101928120 A CNA2007101928120 A CN A2007101928120A CN 200710192812 A CN200710192812 A CN 200710192812A CN 101172100 A CN101172100 A CN 101172100A
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CN
China
Prior art keywords
formulation
protein
antibody
preparation
concentration
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
CNA2007101928120A
Other languages
English (en)
Chinese (zh)
Inventor
J·安德亚
J·L·克莱伦德
C·C·赫苏
X·M·拉姆
D·E·奥维卡谢尔
S·J·夏尔
J·Y·杨
S·S·吴
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.)
Genentech Inc
Original Assignee
Genentech 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24021032&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN101172100(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of CN101172100A publication Critical patent/CN101172100A/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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61P37/08—Antiallergic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Immunology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CNA2007101928120A 1995-07-27 1996-07-23 稳定等渗的冻干蛋白质制剂 Pending CN101172100A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US50801495A 1995-07-27 1995-07-27
US08/508,014 1995-07-27
US08/615,369 1996-03-14

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CNB961958308A Division CN1151842C (zh) 1995-07-27 1996-07-23 稳定等渗的冻干蛋白制剂

Publications (1)

Publication Number Publication Date
CN101172100A true CN101172100A (zh) 2008-05-07

Family

ID=24021032

Family Applications (2)

Application Number Title Priority Date Filing Date
CNA2007101928120A Pending CN101172100A (zh) 1995-07-27 1996-07-23 稳定等渗的冻干蛋白质制剂
CN2007101928065A Expired - Lifetime CN101172099B (zh) 1995-07-27 1996-07-23 稳定等渗的冻干蛋白质制剂

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN2007101928065A Expired - Lifetime CN101172099B (zh) 1995-07-27 1996-07-23 稳定等渗的冻干蛋白质制剂

Country Status (16)

Country Link
EP (1) EP0841946B2 (https=)
JP (1) JP4153560B2 (https=)
CN (2) CN101172100A (https=)
AR (1) AR003468A1 (https=)
AT (1) ATE225185T1 (https=)
AU (1) AU715338B2 (https=)
CA (1) CA2226624C (https=)
DE (1) DE69624116T3 (https=)
DK (1) DK0841946T4 (https=)
ES (1) ES2186796T5 (https=)
IL (1) IL122733A (https=)
MX (1) MX9800760A (https=)
PT (1) PT841946E (https=)
RU (1) RU2229288C2 (https=)
WO (1) WO1997004807A1 (https=)
ZA (2) ZA966075B (https=)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104707146A (zh) * 2013-12-16 2015-06-17 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
CN107854439A (zh) * 2011-03-31 2018-03-30 默沙东公司 针对人程序性死亡受体pd‑1的抗体的稳定制剂和有关的治疗
WO2019019998A1 (zh) * 2017-07-25 2019-01-31 江苏恒瑞医药股份有限公司 一种il-15蛋白复合物药物组合物及其用途
CN110732023A (zh) * 2018-07-18 2020-01-31 江苏恒瑞医药股份有限公司 一种her2抗体药物组合物及其用途
US11633476B2 (en) 2017-05-02 2023-04-25 Merck Sharp & Dohme Llc Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
WO2024017241A1 (en) * 2022-07-18 2024-01-25 Suzhou Transcenta Therapeutics Co., Ltd. Stable pharmaceutical formulation comprising anti-gremlin1 antibody
US12576159B2 (en) 2018-10-31 2026-03-17 Merck Sharp & Dohme Llc Anti-human PD-1 antibody crystals and methods of use thereof

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US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6991790B1 (en) 1997-06-13 2006-01-31 Genentech, Inc. Antibody formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
WO1999045777A1 (en) * 1998-03-10 1999-09-16 The Children's Hospital Of Philadelphia Compositions and methods for treatment of asthma
US6299875B1 (en) 1998-06-04 2001-10-09 Panacea Pharmaceuticals, Llc Methods to block IGE binding to cell surface receptors of mast cells
US6913749B2 (en) 1998-11-02 2005-07-05 Resistentia Pharmaceuticals Ab Immunogenic polypeptides for inducing anti-self IgE responses
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2004041863A2 (en) 2002-11-08 2004-05-21 Ablynx N.V. Single domain antibodies directed against interferon- gamma and uses therefor
EP1558645B1 (en) 2002-11-08 2011-07-27 Ablynx N.V. Stabilized single domain antibodies in pharmaceutical composition adapted for inhalation
EP1900753B1 (en) 2002-11-08 2017-08-09 Ablynx N.V. Method of administering therapeutic polypeptides, and polypeptides therefor
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
DE202006020194U1 (de) * 2006-03-01 2007-12-06 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
CA2676843A1 (en) * 2007-01-29 2008-08-07 Valtion Teknillinen Tutkimuskeskus Method for producing novel ige based reagents
AR065368A1 (es) 2007-02-15 2009-06-03 Astrazeneca Ab Anticuerpos para moleculas de ige
EP2052736A1 (en) * 2007-10-26 2009-04-29 Nycomed Danmark ApS Parathyroid hormone formulations und uses thereof
BRPI0821591A2 (pt) * 2007-12-21 2016-05-03 Inspiration Biopharmaceuticals Inc composição liofilizada e métodos de preparação de composição seca estável do fator ix e de liofilização de formulação farmacêutica
BRPI0820819B1 (pt) * 2007-12-21 2021-06-08 F. Hoffmann-La Roche Ag formulação de anticorpos humanizados b-ly 1 e seu uso
MX344559B (es) 2008-04-29 2016-12-20 Ascendis Pharma As Compuestos de hormona de crecimiento humana recombinante unidos al peg.
CA2738243C (en) * 2008-10-29 2020-09-29 Wyeth Llc Formulations of single domain antigen binding molecules
BRPI0919879A2 (pt) 2008-10-29 2016-02-16 Wyeth Llc métodos para purificação de moléculas de ligação a antígeno de domínio único
MX337432B (es) 2009-12-15 2016-03-04 Ascendis Pharma As Composicion de la hormona del crecimiento seca enlazada transitoriamente a un portador del polimero.
ES2993140T3 (en) 2010-04-02 2024-12-23 Amunix Pharmaceuticals Inc Binding fusion proteins, binding fusion protein-drug conjugates, xten-drug conjugates and methods of making and using same
CN102533704A (zh) * 2010-12-30 2012-07-04 上海雅心生物技术有限公司 即配即用型的胰蛋白酶制剂
CN107233569B (zh) * 2011-10-25 2021-08-31 普罗西纳生物科学有限公司 抗体制剂和方法
EP3689335A1 (en) 2013-09-27 2020-08-05 Hanmi Pharm. Co., Ltd. Sustained type human growth hormone preparation
SG11201703870UA (en) 2014-11-18 2017-06-29 Ascendis Pharma Endocrinology Div As Novel polymeric hgh prodrugs
PT3220892T (pt) 2014-11-21 2021-11-05 Ascendis Pharma Endocrinology Div A/S Formas de dosagem de hormona do crescimento de longa ação
GB201610198D0 (en) 2016-06-10 2016-07-27 Ucb Biopharma Sprl Anti-ige antibodies
KR20220098056A (ko) * 2018-02-09 2022-07-08 제넨테크, 인크. 비만 세포 매개 염증성 질환에 대한 치료 및 진단 방법
AU2020233198B2 (en) 2019-03-04 2025-05-15 Ascendis Pharma Endocrinology Division A/S Long-acting growth hormone dosage forms with superior efficacy to daily somatropin
CN113827717A (zh) * 2020-06-23 2021-12-24 三生国健药业（上海）股份有限公司 抗her2单克隆抗体冻干制剂及制备方法
CA3185192A1 (en) 2020-07-10 2022-01-13 Sujun DENG Anti-ige engineered antibody and application thereof

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DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
AU616916B2 (en) * 1987-11-20 1991-11-14 Kissei Pharmaceutical Co. Ltd. 4h-quinolizin-4-one compounds exhibiting therapeutic activities
AU618317B2 (en) * 1987-12-31 1991-12-19 Tanox Biosystems, Inc. Unique antigenic epitopes on ige-bearing b lymphocytes
US5011676A (en) * 1990-03-27 1991-04-30 Thomas Jefferson University Method to directly radiolabel antibodies for diagnostic imaging and therapy
US5290764A (en) * 1992-01-14 1994-03-01 The Dupont Merck Pharmaceutical Company Stabilization of active plasminogen activator inhibitor-1
EP0651819A1 (en) * 1992-03-20 1995-05-10 Immunet Methods for human monoclonal antibody production
JPH07118168A (ja) * 1993-10-19 1995-05-09 Tomoyasu Ra ＩｇＥ産生抑制剤
ES2219640T3 (es) * 1992-09-24 2004-12-01 Novartis Ag Anticuerpos monoclonales reformados contra un isotopo de inmunoglobulina.
DE4344824C1 (de) * 1993-12-28 1995-08-31 Immuno Ag Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107854439A (zh) * 2011-03-31 2018-03-30 默沙东公司 针对人程序性死亡受体pd‑1的抗体的稳定制剂和有关的治疗
CN104707146A (zh) * 2013-12-16 2015-06-17 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
CN104707146B (zh) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
US11633476B2 (en) 2017-05-02 2023-04-25 Merck Sharp & Dohme Llc Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
WO2019019998A1 (zh) * 2017-07-25 2019-01-31 江苏恒瑞医药股份有限公司 一种il-15蛋白复合物药物组合物及其用途
US11273205B2 (en) 2017-07-25 2022-03-15 Jiangsu Hengrui Medicine Co., Ltd. IL-15 protein complex pharmaceutical composition
CN110732023A (zh) * 2018-07-18 2020-01-31 江苏恒瑞医药股份有限公司 一种her2抗体药物组合物及其用途
CN110732023B (zh) * 2018-07-18 2023-06-16 江苏恒瑞医药股份有限公司 一种her2抗体药物组合物及其用途
US12576159B2 (en) 2018-10-31 2026-03-17 Merck Sharp & Dohme Llc Anti-human PD-1 antibody crystals and methods of use thereof
WO2024017241A1 (en) * 2022-07-18 2024-01-25 Suzhou Transcenta Therapeutics Co., Ltd. Stable pharmaceutical formulation comprising anti-gremlin1 antibody

Also Published As

Publication number Publication date
DE69624116T3 (de) 2009-07-09
AU6638196A (en) 1997-02-26
EP0841946B1 (en) 2002-10-02
DE69624116T2 (de) 2003-06-18
CN101172099B (zh) 2012-02-15
JP4153560B2 (ja) 2008-09-24
AU715338B2 (en) 2000-01-20
CN101172099A (zh) 2008-05-07
ES2186796T3 (es) 2003-05-16
ES2186796T5 (es) 2009-04-01
IL122733A0 (en) 1998-08-16
CA2226624A1 (en) 1997-02-13
DE69624116D1 (de) 2002-11-07
IL122733A (en) 2001-09-13
EP0841946A1 (en) 1998-05-20
EP0841946B2 (en) 2008-10-15
DK0841946T3 (da) 2003-02-10
DK0841946T4 (da) 2009-02-16
AR003468A1 (es) 1998-08-05
MX9800760A (es) 1998-04-30
RU2229288C2 (ru) 2004-05-27
ZA966075B (en) 1998-01-19
CA2226624C (en) 2013-07-16
PT841946E (pt) 2003-02-28
JPH11510172A (ja) 1999-09-07
WO1997004807A1 (en) 1997-02-13
ZA966240B (en) 1998-01-23
ATE225185T1 (de) 2002-10-15

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