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WO2009003010A3 - Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution - Google Patents

Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution Download PDF

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Publication number
WO2009003010A3
WO2009003010A3 PCT/US2008/068136 US2008068136W WO2009003010A3 WO 2009003010 A3 WO2009003010 A3 WO 2009003010A3 US 2008068136 W US2008068136 W US 2008068136W WO 2009003010 A3 WO2009003010 A3 WO 2009003010A3
Authority
WO
WIPO (PCT)
Prior art keywords
organopolysiloxane
protein
aggregation
evaluating
methods
Prior art date
Application number
PCT/US2008/068136
Other languages
French (fr)
Other versions
WO2009003010A2 (en
Inventor
John Frank Carpenter
Theodore Randolph
John Paul Gabrielson
Jean-Bernard Hamel
Original Assignee
Becton Dickinson Co
Univ Colorado At Denver And He
John Frank Carpenter
Theodore Randolph
John Paul Gabrielson
Jean-Bernard Hamel
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 Becton Dickinson Co, Univ Colorado At Denver And He, John Frank Carpenter, Theodore Randolph, John Paul Gabrielson, Jean-Bernard Hamel filed Critical Becton Dickinson Co
Priority to CN201610529593.XA priority Critical patent/CN106443002A/en
Priority to PCT/US2008/080721 priority patent/WO2009055427A2/en
Priority to EP20100164045 priority patent/EP2237038B1/en
Priority to US12/739,009 priority patent/US8633034B2/en
Priority to EP08841038.6A priority patent/EP2201380B1/en
Priority to CN200880119613XA priority patent/CN101889209A/en
Priority to ES10164045.6T priority patent/ES2543735T3/en
Priority to JP2010531196A priority patent/JP5081976B2/en
Publication of WO2009003010A2 publication Critical patent/WO2009003010A2/en
Publication of WO2009003010A3 publication Critical patent/WO2009003010A3/en
Priority to JP2012154844A priority patent/JP5978034B2/en
Priority to US14/139,604 priority patent/US20140110297A1/en

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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/80—Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/82—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a precipitate or turbidity
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10—Investigating individual particles
    • G01N15/14—Optical investigation techniques, e.g. flow cytometry
    • G01N15/149—Optical investigation techniques, e.g. flow cytometry specially adapted for sorting particles, e.g. by their size or optical properties
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N2015/0092—Monitoring flocculation or agglomeration

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Plasma & Fusion (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and non-ionic surfactant.
PCT/US2008/068136 2007-06-25 2008-06-25 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution WO2009003010A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CN200880119613XA CN101889209A (en) 2007-10-22 2008-10-22 Method for evaluating protein aggregation in organopolysiloxane-containing suspensions and medical articles coated with organopolysiloxane-containing solutions
PCT/US2008/080721 WO2009055427A2 (en) 2007-10-22 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
EP20100164045 EP2237038B1 (en) 2007-10-22 2008-10-22 Medical articles coated with organopolysiloxane containing a protein solution and non-ionic surfactant
US12/739,009 US8633034B2 (en) 2007-06-25 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
EP08841038.6A EP2201380B1 (en) 2007-10-22 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
CN201610529593.XA CN106443002A (en) 2007-10-22 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organic polysiloxane
ES10164045.6T ES2543735T3 (en) 2007-10-22 2008-10-22 Medical articles coated with organopolysiloxane containing a protein solution and a non-ionic surfactant
JP2010531196A JP5081976B2 (en) 2007-10-22 2008-10-22 Method for assessing protein aggregation in suspensions containing organopolysiloxanes
JP2012154844A JP5978034B2 (en) 2007-10-22 2012-07-10 Method for assessing protein aggregation in a suspension comprising an organopolysiloxane and a medical article coated with an organopolysiloxane containing a protein solution
US14/139,604 US20140110297A1 (en) 2007-06-25 2013-12-23 "Medical Articles Coated With Organopolysiloxane Containing a Protein Solution"

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93717907P 2007-06-25 2007-06-25
US60/937,179 2007-06-25

Related Child Applications (3)

Application Number Title Priority Date Filing Date
PCT/US2008/080721 Continuation-In-Part WO2009055427A2 (en) 2007-06-25 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
US12/739,009 Continuation-In-Part US8633034B2 (en) 2007-06-25 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution
US12/739,009 Division US8633034B2 (en) 2007-06-25 2008-10-22 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution

Publications (2)

Publication Number Publication Date
WO2009003010A2 WO2009003010A2 (en) 2008-12-31
WO2009003010A3 true WO2009003010A3 (en) 2009-02-12

Family

ID=40186268

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/068136 WO2009003010A2 (en) 2007-06-25 2008-06-25 Methods for evaluating the aggregation of a protein in a suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution

Country Status (1)

Country Link
WO (1) WO2009003010A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2237038B1 (en) 2007-10-22 2015-04-29 Becton Dickinson and Company Medical articles coated with organopolysiloxane containing a protein solution and non-ionic surfactant
US8802603B2 (en) 2010-06-17 2014-08-12 Becton, Dickinson And Company Medical components having coated surfaces exhibiting low friction and low reactivity
KR102557798B1 (en) 2014-12-23 2023-07-19 메르츠 파마 게엠베하 운트 코. 카가아 Botulinum Toxin Prefilled Containers
AU2015381351B2 (en) 2015-02-03 2020-05-14 Merz Pharma Gmbh & Co. Kgaa Botulinum toxin prefilled container
ES2797298T3 (en) 2016-02-10 2020-12-01 Becton Dickinson France Procedure to evaluate the stability of a protein-based formulation

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6525084B2 (en) * 1998-07-23 2003-02-25 Novo Nordisk A/S Stable pharmaceutical formulation
US20030072807A1 (en) * 2000-12-22 2003-04-17 Wong Joseph Chung-Tak Solid particulate antifungal compositions for pharmaceutical use
US6638519B1 (en) * 1999-11-08 2003-10-28 L'oreal Composition for topical application comprising a sugar and its cosmetic uses
US20050053598A1 (en) * 2003-02-10 2005-03-10 Burke David J. Immunoglobulin formulation and method of preparation thereof
US20050123947A1 (en) * 1997-09-23 2005-06-09 California Institute Of Technology Methods and systems for molecular fingerprinting
US20060051353A1 (en) * 2004-05-14 2006-03-09 Jean-Frederic Colombel Methods and compositions to evaluate antibody treatment response

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050123947A1 (en) * 1997-09-23 2005-06-09 California Institute Of Technology Methods and systems for molecular fingerprinting
US6525084B2 (en) * 1998-07-23 2003-02-25 Novo Nordisk A/S Stable pharmaceutical formulation
US6638519B1 (en) * 1999-11-08 2003-10-28 L'oreal Composition for topical application comprising a sugar and its cosmetic uses
US20030072807A1 (en) * 2000-12-22 2003-04-17 Wong Joseph Chung-Tak Solid particulate antifungal compositions for pharmaceutical use
US20050053598A1 (en) * 2003-02-10 2005-03-10 Burke David J. Immunoglobulin formulation and method of preparation thereof
US20060051353A1 (en) * 2004-05-14 2006-03-09 Jean-Frederic Colombel Methods and compositions to evaluate antibody treatment response

Also Published As

Publication number Publication date
WO2009003010A2 (en) 2008-12-31

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