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WO2006014965A3 - Preparation pharmaceutique et processus - Google Patents

Preparation pharmaceutique et processus Download PDF

Info

Publication number
WO2006014965A3
WO2006014965A3 PCT/US2005/026506 US2005026506W WO2006014965A3 WO 2006014965 A3 WO2006014965 A3 WO 2006014965A3 US 2005026506 W US2005026506 W US 2005026506W WO 2006014965 A3 WO2006014965 A3 WO 2006014965A3
Authority
WO
WIPO (PCT)
Prior art keywords
lyophilization
protein
bulking agent
saccharide
agent
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.)
Ceased
Application number
PCT/US2005/026506
Other languages
English (en)
Other versions
WO2006014965A2 (fr
WO2006014965A9 (fr
Inventor
Rajesh Krishnamurthy
Raj Suryanarayanan
Xiangmin Liao
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.)
Human Genome Sciences Inc
Original Assignee
Human Genome Sciences 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 Human Genome Sciences Inc filed Critical Human Genome Sciences Inc
Publication of WO2006014965A2 publication Critical patent/WO2006014965A2/fr
Publication of WO2006014965A9 publication Critical patent/WO2006014965A9/fr
Priority to US11/626,264 priority Critical patent/US20070196364A1/en
Anticipated expiration legal-status Critical
Publication of WO2006014965A3 publication Critical patent/WO2006014965A3/fr
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un processus de lyophilisation ou de déshydratation de produit congelé d'un produit pharmaceutique et une préparation liquide qui convient pour la lyophilisation. Cette invention concerne en particulier un processus de lyophilisation ou de déshydratation de produit congelé d'une préparation liquide qui comprend un agent actif protéine, un agent gonflant et un agent stabilisant saccharide. Le rapport saccharide sur agent gonflant et la concentration de protéines de cette préparation sont des facteurs importants qui ont un effet sur la cristallisation de l'agent gonflant pendant la lyophilisation et le stockage comme des conditions de traitement le sont. Dans un mode de réalisation, le saccharides est un disaccharide tels que du saccharose et l'agent gonflant cristallin est du mannitol. La protéine peut être une protéine anticorps ou non.
PCT/US2005/026506 2004-07-27 2005-07-27 Preparation pharmaceutique et processus Ceased WO2006014965A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/626,264 US20070196364A1 (en) 2004-07-27 2007-01-23 Pharmaceutical Formulation and Process

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US59110204P 2004-07-27 2004-07-27
US60/591,102 2004-07-27
US67783805P 2005-05-05 2005-05-05
US60/677,838 2005-05-05

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/626,264 Continuation-In-Part US20070196364A1 (en) 2004-07-27 2007-01-23 Pharmaceutical Formulation and Process

Publications (3)

Publication Number Publication Date
WO2006014965A2 WO2006014965A2 (fr) 2006-02-09
WO2006014965A9 WO2006014965A9 (fr) 2006-03-30
WO2006014965A3 true WO2006014965A3 (fr) 2007-03-29

Family

ID=35787773

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/026506 Ceased WO2006014965A2 (fr) 2004-07-27 2005-07-27 Preparation pharmaceutique et processus

Country Status (1)

Country Link
WO (1) WO2006014965A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12246025B2 (en) 2018-03-21 2025-03-11 Genmab A/S Methods of treating cancer with a combination of a platinum-based agent and an anti-tissue factor antibody-drug conjugate
US12324841B2 (en) 2018-05-07 2025-06-10 Genmab A/S Methods of treating cancer with a combination of an anti-PD-1 antibody and an anti-tissue factor antibody-drug conjugate
US12453781B2 (en) 2018-10-30 2025-10-28 Genmab A/S Methods of treating cancer with a combination of an anti-VEGF antibody and an anti-tissue factor antibody-drug conjugate

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2390354T3 (es) * 2005-07-22 2012-11-12 Amgen, Inc Liofilizados de proteínas concentrados, procedimientos y usos
CA2671571A1 (fr) * 2006-12-06 2008-06-12 Wyeth Formulations a concentration elevee en proteines contenant du mannitol
CA2677937A1 (fr) * 2007-02-16 2008-08-21 Wyeth Utilisation de saccharose pour supprimer une agregation de proteines provoquee par du mannitol
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
WO2015075201A1 (fr) 2013-11-21 2015-05-28 Genmab A/S Formulation lyophilisée de conjugués anticorps-médicaments
CN107660149B (zh) 2015-04-21 2021-04-27 舒泰神（北京）生物制药股份有限公司 一种神经生长因子组合物及注射粉剂
WO2016169453A1 (fr) 2015-04-21 2016-10-27 舒泰神（北京）生物制药股份有限公司 Composition de facteur de croissance nerveux et poudre injectable
US12115227B2 (en) 2016-01-13 2024-10-15 Genmab A/S Formulation for antibody and drug conjugate thereof
CN110606868A (zh) * 2018-10-30 2019-12-24 中国科学院化学研究所 一种制备多肽或蛋白质单晶或无定型物的方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997004801A1 (fr) * 1995-07-27 1997-02-13 Genentech, Inc. Formulation de proteine lyophilisee isotonique et stable
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US20030113316A1 (en) * 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997004801A1 (fr) * 1995-07-27 1997-02-13 Genentech, Inc. Formulation de proteine lyophilisee isotonique et stable
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US20030113316A1 (en) * 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12246025B2 (en) 2018-03-21 2025-03-11 Genmab A/S Methods of treating cancer with a combination of a platinum-based agent and an anti-tissue factor antibody-drug conjugate
US12324841B2 (en) 2018-05-07 2025-06-10 Genmab A/S Methods of treating cancer with a combination of an anti-PD-1 antibody and an anti-tissue factor antibody-drug conjugate
US12453781B2 (en) 2018-10-30 2025-10-28 Genmab A/S Methods of treating cancer with a combination of an anti-VEGF antibody and an anti-tissue factor antibody-drug conjugate

Also Published As

Publication number Publication date
WO2006014965A2 (fr) 2006-02-09
WO2006014965A9 (fr) 2006-03-30

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