CN1604788B - 高浓度蛋白制剂及其制备方法 - Google Patents

高浓度蛋白制剂及其制备方法 Download PDF

Info

Publication number
CN1604788B
CN1604788B CN028251857A CN02825185A CN1604788B CN 1604788 B CN1604788 B CN 1604788B CN 028251857 A CN028251857 A CN 028251857A CN 02825185 A CN02825185 A CN 02825185A CN 1604788 B CN1604788 B CN 1604788B
Authority
CN
China
Prior art keywords
weight
protein
pharmaceutical composition
mixture
precipitation
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
CN028251857A
Other languages
English (en)
Chinese (zh)
Other versions
CN1604788A (zh
Inventor
杰弗里·B·埃特
阿德里安·C·萨马尼戈
约翰·F·卡彭特
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.)
RxKinetix Inc
University of Colorado System
Original Assignee
RxKinetix Inc
University of Colorado System
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 RxKinetix Inc, University of Colorado System filed Critical RxKinetix Inc
Publication of CN1604788A publication Critical patent/CN1604788A/zh
Application granted granted Critical
Publication of CN1604788B publication Critical patent/CN1604788B/zh
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Images

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
    • A61K9/0012—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
    • A61K49/08—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10—Organic compounds
    • A61K49/14—Peptides, e.g. proteins
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN028251857A 2001-10-16 2002-10-16 高浓度蛋白制剂及其制备方法 Expired - Fee Related CN1604788B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33021301P 2001-10-16 2001-10-16
US60/330,213 2001-10-16
PCT/US2002/032872 WO2003032907A2 (en) 2001-10-16 2002-10-16 High-concentration protein formulations and method of manufacture

Publications (2)

Publication Number Publication Date
CN1604788A CN1604788A (zh) 2005-04-06
CN1604788B true CN1604788B (zh) 2013-04-17

Family

ID=23288780

Family Applications (1)

Application Number Title Priority Date Filing Date
CN028251857A Expired - Fee Related CN1604788B (zh) 2001-10-16 2002-10-16 高浓度蛋白制剂及其制备方法

Country Status (8)

Country Link
US (1) US8372798B2 (https=)
EP (1) EP1441748A4 (https=)
JP (1) JP2005523882A (https=)
CN (1) CN1604788B (https=)
AU (1) AU2002335815A1 (https=)
BR (1) BR0213298A (https=)
MX (1) MXPA04003640A (https=)
WO (1) WO2003032907A2 (https=)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
AU2002213441B2 (en) 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US20050158303A1 (en) * 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
CN1798575A (zh) 2003-04-04 2006-07-05 健泰科生物技术公司 高浓度抗体和蛋白制剂
JP2007538048A (ja) * 2004-05-17 2007-12-27 アレス トレーディング ソシエテ アノニム ヒドロゲル・インターフェロン製剤
EP2044934A1 (en) * 2007-10-01 2009-04-08 Institut National De La Sante Et De La Recherche Medicale (Inserm) Dispersion of poloxamer-protein particles, methods of manufacturing and uses thereof
AR076640A1 (es) * 2009-03-06 2011-06-29 Genentech Inc Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura
HUE047173T2 (hu) 2010-03-01 2020-04-28 Bayer Healthcare Llc Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen
KR20200032244A (ko) * 2012-03-07 2020-03-25 아미쿠스 세라퓨틱스, 인코포레이티드 폼페병의 치료를 위한 고농도 알파-글루코시다제 조성물
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2016054231A1 (en) 2014-09-30 2016-04-07 Amicus Therapeutics, Inc. Highly potent acid alpha-glucosidase with enhanced carbohydrates
KR102510941B1 (ko) 2015-12-30 2023-03-20 아미쿠스 세라퓨틱스, 인코포레이티드 폼페병 치료용의 강화된 산 알파-글루코시다제
US10227577B2 (en) 2016-03-30 2019-03-12 Amicus Therapeutics, Inc. Method for selection of high M6P recombinant proteins
IL325155A (en) 2016-03-30 2026-02-01 Amicus Therapeutics Inc Formulations containing recombinant acid alpha-glucosidase
EP3624831B1 (en) 2017-05-15 2023-03-29 Amicus Therapeutics, Inc. Recombinant human acid alpha-glucosidase
WO2021042090A2 (en) * 2020-11-27 2021-03-04 Schott Ag System for long time storage of pharmaceutical compositions at low temperatures

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5488034A (en) * 1993-02-02 1996-01-30 Xoma Corporation Pharmaceutical composition comprising BPI proteins

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT359641B (de) * 1978-09-19 1980-11-25 Immuno Ag Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates
US5861158A (en) * 1993-11-17 1999-01-19 The United States Of America As Represented By The Deptartment Of Health And Human Services Method and composition for transfer of active tumor-specific immunization from an immunized allogeneic bone marrow donor
AU692506B2 (en) * 1993-11-17 1998-06-11 Ibah, Inc. Transparent liquid for encapsulated drug delivery
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US5702717A (en) * 1995-10-25 1997-12-30 Macromed, Inc. Thermosensitive biodegradable polymers based on poly(ether-ester)block copolymers
US20050019325A1 (en) * 1996-01-08 2005-01-27 Carter Paul J. WSX receptor agonist antibodies
US5861174A (en) * 1996-07-12 1999-01-19 University Technology Corporation Temperature sensitive gel for sustained delivery of protein drugs
US6228360B1 (en) * 1998-08-19 2001-05-08 Ajinomoto Co., Inc. Antithrombotic agent and humanized anti-von Willebrand factor monoclonal antibody
BR0111948A (pt) * 2000-06-26 2004-08-24 Rxkinetix Inc Composição para entrega de fator de crescimento hematopoiético
US6613907B2 (en) * 2000-11-08 2003-09-02 Amr Technology, Inc. Process for the production of piperidine derivatives with microorganisms

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5488034A (en) * 1993-02-02 1996-01-30 Xoma Corporation Pharmaceutical composition comprising BPI proteins

Also Published As

Publication number Publication date
AU2002335815A1 (en) 2003-04-28
US8372798B2 (en) 2013-02-12
EP1441748A4 (en) 2007-07-11
CN1604788A (zh) 2005-04-06
WO2003032907A2 (en) 2003-04-24
BR0213298A (pt) 2006-11-07
US20030092607A1 (en) 2003-05-15
WO2003032907A3 (en) 2004-02-19
JP2005523882A (ja) 2005-08-11
WO2003032907A9 (en) 2005-01-06
MXPA04003640A (es) 2005-04-11
EP1441748A2 (en) 2004-08-04

Similar Documents

Publication Publication Date Title
CN1604788B (zh) 高浓度蛋白制剂及其制备方法
US11672865B2 (en) Viscosity-reducing excipient compounds for protein formulations
US11806399B2 (en) Excipient compounds for biopolymer formulations
CA3129181C (en) Excipient compounds for biopolymer formulations
JP2000514811A (ja) タンパク質医薬の持続送達のための温度感受性ゲル
JP2004532262A (ja) 安定な抗体液体製剤
JP2007529508A (ja) 改良された放出プロファイルを持つヒドロゲル微小球
US20230065872A1 (en) Excipient compounds for protein processing
CA3053909A1 (en) Excipient compounds for protein processing
CA3120023A1 (en) Excipient compounds for protein processing
US20210379185A1 (en) Excipient compounds for protein processing

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20130417

Termination date: 20171016

CF01 Termination of patent right due to non-payment of annual fee