BR0213298A - formulações com alta concentração de proteìna e processo de fabricação - Google Patents

formulações com alta concentração de proteìna e processo de fabricação

Info

Publication number
BR0213298A
BR0213298A BRPI0213298-2A BR0213298A BR0213298A BR 0213298 A BR0213298 A BR 0213298A BR 0213298 A BR0213298 A BR 0213298A BR 0213298 A BR0213298 A BR 0213298A
Authority
BR
Brazil
Prior art keywords
concentrated mixture
manufacturing process
high protein
protein formulations
protein
Prior art date
Application number
BRPI0213298-2A
Other languages
English (en)
Inventor
Jeffrey B Etter
Adrian C Samaniego
John F Carpenter
Original Assignee
Rxkinetix Inc
Univ Colorado
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, Univ Colorado filed Critical Rxkinetix Inc
Publication of BR0213298A publication Critical patent/BR0213298A/pt

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
    • A61K9/0012—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

Abstract

"FORMULAçõES COM ALTA CONCENTRAçãO DE PROTEìNAS E PROCESSO DE FABRICAçãO". São fornecidos uma composição farmacêutica, envolvendo uma mistura concentrada de uma proteína precipitada e um meio líquido, e um processo para fabricação da mistura concentrada. A mistura concentrada pode ser fabricada por precipitação de uma proteína com um agente de precipitação de polímero biocompatível, seguida por remoção de líquido suficiente para concentrar a mistura resultante até o grau desejado. A proteína precipitada pode ser armazenada durante um tempo significativo na mistura concentrada, tal como um intermediário entre, estágios de processamento durante operações de fabricação.
BRPI0213298-2A 2001-10-16 2002-10-16 formulações com alta concentração de proteìna e processo de fabricação BR0213298A (pt)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
BR0213298A true BR0213298A (pt) 2006-11-07

Family

ID=23288780

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0213298-2A BR0213298A (pt) 2001-10-16 2002-10-16 formulações com alta concentração de proteìna e processo de fabricação

Country Status (8)

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

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DE60139944D1 (de) * 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
PT1610820E (pt) * 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
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
EA012205B1 (ru) * 2004-05-17 2009-08-28 Арес Трейдинг С.А. Гидрогелевые препараты интерферона
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
SG174258A1 (en) * 2009-03-06 2011-10-28 Genentech Inc Antibody formulation
SI2542257T1 (en) 2010-03-01 2018-01-31 Bayer Healthcare Llc Optimized monoclonal antibodies against Tissue Factor Pathway Inhibitor (TFPI)
KR20210062731A (ko) * 2012-03-07 2021-05-31 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
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
US20160074515A1 (en) 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
PL3201320T3 (pl) 2014-09-30 2024-03-18 Amicus Therapeutics, Inc. Bardzo silnie działająca kwasowa alfa-glukozydaza ze zwiększoną zawartością węglowodanów
WO2017117407A1 (en) 2015-12-30 2017-07-06 Amicus Therapeutics, Inc. Augmented acid alpha-glucosidase for the treatment of pompe disease
SG11201808455VA (en) 2016-03-30 2018-10-30 Amicus Therapeutics Inc Formulations comprising recombinant acid alpha-glucosidase
PE20190127A1 (es) 2016-03-30 2019-01-17 Amicus Therapeutics Inc Metodo para seleccionar proteinas recombinantes ricas en m6p
WO2021042090A2 (en) * 2020-11-27 2021-03-04 Schott Ag System for long time storage of pharmaceutical compositions at low temperatures

Family Cites Families (11)

* 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
CA2155005C (en) * 1993-02-02 1999-04-06 Weldon Courtney Mcgregor Pharmaceutical compositions containing bactericidal permeability increasing protein and a surfactant
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
WO1995014037A1 (en) * 1993-11-17 1995-05-26 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
AU2001273041A1 (en) * 2000-06-26 2002-01-08 Board Of Regents Of The University Of Nebraska Methods for use of delivery composition for expanding, activating, committing ormobilizing one or more pluripotent, self-renewing and committed stem cells
US6613907B2 (en) * 2000-11-08 2003-09-02 Amr Technology, Inc. Process for the production of piperidine derivatives with microorganisms

Also Published As

Publication number Publication date
EP1441748A4 (en) 2007-07-11
US20030092607A1 (en) 2003-05-15
US8372798B2 (en) 2013-02-12
AU2002335815A1 (en) 2003-04-28
MXPA04003640A (es) 2005-04-11
WO2003032907A3 (en) 2004-02-19
JP2005523882A (ja) 2005-08-11
WO2003032907A2 (en) 2003-04-24
CN1604788B (zh) 2013-04-17
WO2003032907A9 (en) 2005-01-06
EP1441748A2 (en) 2004-08-04
CN1604788A (zh) 2005-04-06

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements