WO2006088576A3 - Polypeptide formulations and methods for making, using and characterizing them - Google Patents

Polypeptide formulations and methods for making, using and characterizing them Download PDF

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Publication number
WO2006088576A3
WO2006088576A3 PCT/US2006/001048 US2006001048W WO2006088576A3 WO 2006088576 A3 WO2006088576 A3 WO 2006088576A3 US 2006001048 W US2006001048 W US 2006001048W WO 2006088576 A3 WO2006088576 A3 WO 2006088576A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
methods
characterizing
making
polypeptide formulations
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/US2006/001048
Other languages
French (fr)
Other versions
WO2006088576A2 (en
Inventor
Poonam S Gulati
Sarnath Chattaraj
Elango Minnoor
Eugene Levin
Xiao Zhu
Antwerp William Peter Van
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.)
Medtronic Minimed Inc
Original Assignee
Medtronic Minimed 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 Medtronic Minimed Inc filed Critical Medtronic Minimed Inc
Priority to AT06718158T priority Critical patent/ATE473757T1/en
Priority to CA2597367A priority patent/CA2597367C/en
Priority to JP2007556142A priority patent/JP4948424B2/en
Priority to EP06718158A priority patent/EP1851536B1/en
Priority to DE602006015427T priority patent/DE602006015427D1/en
Priority to DK06718158.6T priority patent/DK1851536T3/en
Publication of WO2006088576A2 publication Critical patent/WO2006088576A2/en
Publication of WO2006088576A3 publication Critical patent/WO2006088576A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/54—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/06—Preparation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/74—Optical detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/902—Oxidoreductases (1.)
    • G01N2333/904—Oxidoreductases (1.) acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Emergency Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Embodiments of the invention include polypeptide formulations and methods for making, using and characterizing them. Embodiment of the invention include stabilized polypeptide formulations, for example stable glucose oxidase formulations that can be used with glucose sensors used in the management of diabetes. Another embodiment of the invention includes methods to characterize the concentration of nonionic surfactants in stabilized polypeptide formulation for example stable insulin formulations that can be used in the treatment of diabetes.
PCT/US2006/001048 2005-02-17 2006-01-12 Polypeptide formulations and methods for making, using and characterizing them Ceased WO2006088576A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AT06718158T ATE473757T1 (en) 2005-02-17 2006-01-12 STABLE GLUCOSE OXIDASE FORMULATIONS AND METHODS FOR THE PRODUCTION AND USE THEREOF
CA2597367A CA2597367C (en) 2005-02-17 2006-01-12 Glucose oxidase formulations and methods for making and using them
JP2007556142A JP4948424B2 (en) 2005-02-17 2006-01-12 Glucose oxidase composition and production method thereof, sensor device for implantation in mammal using glucose oxidase composition
EP06718158A EP1851536B1 (en) 2005-02-17 2006-01-12 Stable glucose oxidase formulations and methods for making and using them
DE602006015427T DE602006015427D1 (en) 2005-02-17 2006-01-12 STABLE GLUCOSEOXIDASE FORMULATIONS AND METHOD FOR THE PRODUCTION AND USE THEREOF
DK06718158.6T DK1851536T3 (en) 2005-02-17 2006-01-12 Stable glucose oxidase formulations and processes for their preparation and use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/060,255 2005-02-17
US11/060,255 US7241586B2 (en) 2005-02-17 2005-02-17 Polypeptide formulations and methods for making, using and characterizing them

Publications (2)

Publication Number Publication Date
WO2006088576A2 WO2006088576A2 (en) 2006-08-24
WO2006088576A3 true WO2006088576A3 (en) 2007-02-08

Family

ID=36423621

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/001048 Ceased WO2006088576A2 (en) 2005-02-17 2006-01-12 Polypeptide formulations and methods for making, using and characterizing them

Country Status (8)

Country Link
US (2) US7241586B2 (en)
EP (1) EP1851536B1 (en)
JP (1) JP4948424B2 (en)
AT (1) ATE473757T1 (en)
CA (1) CA2597367C (en)
DE (1) DE602006015427D1 (en)
DK (1) DK1851536T3 (en)
WO (1) WO2006088576A2 (en)

Cited By (3)

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US8954128B2 (en) 2008-03-28 2015-02-10 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9173606B2 (en) 2008-03-28 2015-11-03 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9414777B2 (en) 2004-07-13 2016-08-16 Dexcom, Inc. Transcutaneous analyte sensor

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US8527026B2 (en) 1997-03-04 2013-09-03 Dexcom, Inc. Device and method for determining analyte levels
US6001067A (en) 1997-03-04 1999-12-14 Shults; Mark C. Device and method for determining analyte levels
US20030032874A1 (en) 2001-07-27 2003-02-13 Dexcom, Inc. Sensor head for use with implantable devices
US8364229B2 (en) 2003-07-25 2013-01-29 Dexcom, Inc. Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise
US7828728B2 (en) 2003-07-25 2010-11-09 Dexcom, Inc. Analyte sensor
US7613491B2 (en) 2002-05-22 2009-11-03 Dexcom, Inc. Silicone based membranes for use in implantable glucose sensors
EP1648298A4 (en) 2003-07-25 2010-01-13 Dexcom Inc Oxygen enhancing membrane systems for implantable devices
US9763609B2 (en) 2003-07-25 2017-09-19 Dexcom, Inc. Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise
US7920906B2 (en) 2005-03-10 2011-04-05 Dexcom, Inc. System and methods for processing analyte sensor data for sensor calibration
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US8277713B2 (en) 2004-05-03 2012-10-02 Dexcom, Inc. Implantable analyte sensor
US20070045902A1 (en) 2004-07-13 2007-03-01 Brauker James H Analyte sensor
US8886272B2 (en) 2004-07-13 2014-11-11 Dexcom, Inc. Analyte sensor
US8744546B2 (en) 2005-05-05 2014-06-03 Dexcom, Inc. Cellulosic-based resistance domain for an analyte sensor
US20200037875A1 (en) 2007-05-18 2020-02-06 Dexcom, Inc. Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise
US8512731B2 (en) * 2007-11-13 2013-08-20 Medtronic Minimed, Inc. Antimicrobial coatings for medical devices and methods for making and using them
US20090275815A1 (en) * 2008-03-21 2009-11-05 Nova Biomedical Corporation Temperature-compensated in-vivo sensor
US11730407B2 (en) 2008-03-28 2023-08-22 Dexcom, Inc. Polymer membranes for continuous analyte sensors
EP4549933A3 (en) 2008-09-19 2025-05-21 DexCom, Inc. Particle-containing membrane and particulate electrode for analyte sensors
WO2010099507A1 (en) * 2009-02-26 2010-09-02 Abbott Diabetes Care Inc. Improved analyte sensors and methods of making and using the same
US9237864B2 (en) 2009-07-02 2016-01-19 Dexcom, Inc. Analyte sensors and methods of manufacturing same
CN102749408B (en) * 2011-04-21 2015-08-19 天士力金纳生物技术（天津）有限公司 The detection method of decomposition agent content in a kind of subunit influenza vaccine
CN104458969B (en) * 2014-12-31 2016-05-11 深圳康泰生物制品股份有限公司 The assay method of Triton X-100 residual quantity in the HBsAg stoste that recombinant Saccharomyces cerevisiae is expressed
HRP20250718T1 (en) * 2016-08-15 2025-08-15 F. Hoffmann-La Roche Ag CHROMATOGRAPHIC METHOD FOR QUANTIFICATION OF NON-IONIC SURFACTANT IN A COMPOSITION CONTAINING NON-IONIC SURFACTANT AND POLYPEPTIDE
CN109406698B (en) * 2018-11-30 2020-12-25 广州中科检测技术服务有限公司 Method for measuring content of single-chain substituted dimethyl benzyl ammonium chloride by HPLC
JP7732996B2 (en) * 2020-03-20 2025-09-02 グラクソスミスクライン、インテレクチュアル、プロパティー、ディベロップメント、リミテッド How to Detect Polysorbates
CN112710751A (en) * 2020-12-19 2021-04-27 无锡济煜山禾药业股份有限公司 Method for measuring tween 80 content in Xingnaojing injection

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9414777B2 (en) 2004-07-13 2016-08-16 Dexcom, Inc. Transcutaneous analyte sensor
US8954128B2 (en) 2008-03-28 2015-02-10 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9173606B2 (en) 2008-03-28 2015-11-03 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9173607B2 (en) 2008-03-28 2015-11-03 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9549699B2 (en) 2008-03-28 2017-01-24 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9566026B2 (en) 2008-03-28 2017-02-14 Dexcom, Inc. Polymer membranes for continuous analyte sensors
US9572523B2 (en) 2008-03-28 2017-02-21 Dexcom, Inc. Polymer membranes for continuous analyte sensors

Also Published As

Publication number Publication date
CA2597367C (en) 2013-06-25
WO2006088576A2 (en) 2006-08-24
DK1851536T3 (en) 2010-10-25
EP1851536A2 (en) 2007-11-07
ATE473757T1 (en) 2010-07-15
JP2008536097A (en) 2008-09-04
DE602006015427D1 (en) 2010-08-26
US7241586B2 (en) 2007-07-10
US20080113443A1 (en) 2008-05-15
JP4948424B2 (en) 2012-06-06
EP1851536B1 (en) 2010-07-14
CA2597367A1 (en) 2006-08-24
US20060183178A1 (en) 2006-08-17

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