CA2874077C - Method for determining a concentration of a polysorbate species in a mixture - Google Patents

Method for determining a concentration of a polysorbate species in a mixture Download PDF

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Publication number
CA2874077C
CA2874077C CA2874077A CA2874077A CA2874077C CA 2874077 C CA2874077 C CA 2874077C CA 2874077 A CA2874077 A CA 2874077A CA 2874077 A CA2874077 A CA 2874077A CA 2874077 C CA2874077 C CA 2874077C
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Canada
Prior art keywords
polysorbate
proteins
atr
sample
test sample
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CA2874077A
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English (en)
French (fr)
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CA2874077A1 (en
Inventor
Benedicte Gbaguidi
Olivier C. Germay
Sonia Lardau
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GlaxoSmithKline Biologicals SA
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Publication of CA2874077A1 publication Critical patent/CA2874077A1/en
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Classifications

    • 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
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/3577—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing liquids, e.g. polluted water
    • 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
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/55—Specular reflectivity
    • G01N21/552—Attenuated total reflection
    • 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
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/55—Specular reflectivity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/28—Investigating the spectrum
    • 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
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N2021/3595—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using FTIR

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  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA2874077A 2012-05-23 2013-05-21 Method for determining a concentration of a polysorbate species in a mixture Active CA2874077C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261650735P 2012-05-23 2012-05-23
US61/650,735 2012-05-23
PCT/IB2013/001590 WO2013175312A1 (en) 2012-05-23 2013-05-21 Method for determining a concentration of a polysorbate species in a mixture

Publications (2)

Publication Number Publication Date
CA2874077A1 CA2874077A1 (en) 2013-11-28
CA2874077C true CA2874077C (en) 2020-07-07

Family

ID=48916129

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2874077A Active CA2874077C (en) 2012-05-23 2013-05-21 Method for determining a concentration of a polysorbate species in a mixture

Country Status (9)

Country Link
US (1) US9134228B2 (enExample)
EP (1) EP2852828B1 (enExample)
JP (1) JP6129302B2 (enExample)
CN (1) CN104487823B (enExample)
BR (1) BR112014029107B1 (enExample)
CA (1) CA2874077C (enExample)
ES (1) ES2574614T3 (enExample)
IN (1) IN2014KN02807A (enExample)
WO (1) WO2013175312A1 (enExample)

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* Cited by examiner, † Cited by third party
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GB2504928A (en) * 2012-08-06 2014-02-19 Perkinelmer Uk Ltd Diamond attenuated total reflectance spectrum artefact correction
CN103940773B (zh) * 2014-04-09 2016-01-06 清华大学 一种快速测定血必净注射液中吐温-80含量的方法
WO2016114226A1 (ja) * 2015-01-13 2016-07-21 東洋紡株式会社 被処理水の水質評価方法、定量方法および水処理方法
CN105424636B (zh) * 2015-12-29 2018-04-27 南京财经大学 一种粮食真菌污染情况的快速检测方法及其应用
CN115598231B (zh) * 2016-08-15 2025-11-18 豪夫迈·罗氏有限公司 定量包含非离子表面活性剂和多肽的组合物中非离子表面活性剂的层析方法
US11662312B2 (en) * 2017-06-27 2023-05-30 Coriolis Pharma Research GmbH Polysorbate quantification assay
CN112384130B (zh) * 2018-06-28 2024-08-30 贝克顿·迪金森公司 用于标准化血液培养测量系统中的信号的系统和方法
EP3813643A1 (en) * 2018-06-29 2021-05-05 F. Hoffmann-La Roche AG Fully implantable sensor element and method for detecting at least one analyte in a body fluid
TWI870390B (zh) 2019-02-27 2025-01-21 法商賽諾菲公司 以具內標之lc-ms於樣品中進行聚山梨醇酯定量之方法
WO2020223584A1 (en) 2019-05-01 2020-11-05 Trustees Of Boston University Systems and methods for bond-selective transient phase imaging
GB202000670D0 (en) 2020-01-16 2020-03-04 Clinspec Diagnostics Ltd Cell culture analysis
US20230184750A1 (en) * 2020-03-20 2023-06-15 Glaxosmithkline Intellectual Property Development Limited Method for detecting polysorbates
CN113049727B (zh) * 2021-03-08 2024-04-26 哈尔滨瀚邦医疗科技有限公司 一种聚山梨酯80含量的检测方法
CN115078557A (zh) * 2021-03-12 2022-09-20 深圳赛保尔生物药业有限公司 一种蛋白制剂中吐温80含量的检测方法
DE112022001785T5 (de) * 2021-03-26 2024-02-15 Hamamatsu Photonics K.K. Vorrichtung zur abgeschwächten Totalreflexionsspektroskopie und Verfahren zur abgeschwächten Totalreflexionsspektroskopie
AU2022351402A1 (en) * 2021-09-27 2024-01-25 Boehringer Ingelheim International Gmbh Quantification method of polysorbate in aqueous formulations
EP4202413B1 (en) * 2021-12-21 2024-01-31 Bruker Optics GmbH & Co. KG Computer-implemented method for predicting sample properties based on spectral measurements and computer system therefor
CN116297915B (zh) * 2023-02-10 2023-12-01 中国食品药品检定研究院 聚山梨酯类辅料的分析鉴定方法
CN116448709A (zh) * 2023-04-07 2023-07-18 上海佑尼化学有限公司 一种检测清洗剂工作液中非离子乳化剂的方法及其应用

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5866430A (en) * 1996-06-13 1999-02-02 Grow; Ann E. Raman optrode processes and devices for detection of chemicals and microorganisms
US6040191A (en) * 1996-06-13 2000-03-21 Grow; Ann E. Raman spectroscopic method for determining the ligand binding capacity of biologicals
EP1382964A4 (en) * 2001-04-17 2009-06-10 Chugai Pharmaceutical Co Ltd METHOD FOR TENSID QUANTIFICATION
US7255835B2 (en) 2001-09-04 2007-08-14 North Carolina State University Single pass attenuated total reflection fourier transform infrared microscopy apparatus and method for identifying protein secondary structure, surface charge and binding affinity
JP2003232727A (ja) * 2001-12-04 2003-08-22 Japan Organo Co Ltd 水溶液中のスルホン酸基含有有機化合物の定量分析法
US7435600B2 (en) * 2004-06-23 2008-10-14 Johns Manville Infrared methods of measuring the extent of cure of a binder in fibrous products
JP2007117221A (ja) * 2005-10-25 2007-05-17 Hirato Koji Ｆｔｉｒを用いた非侵襲血液検査「光人間ドックシステム」
US20100304406A1 (en) * 2008-09-17 2010-12-02 Cell Signaling Technology, Inc. Protein Phosphorylation by Serine/Threonine Kinases in Insulin Signaling Pathways
CN101943684B (zh) * 2009-07-10 2012-12-05 华北制药集团制剂有限公司 一种聚山梨酯80有关物质的检测方法

Also Published As

Publication number Publication date
US9134228B2 (en) 2015-09-15
BR112014029107A2 (pt) 2017-06-27
JP6129302B2 (ja) 2017-05-17
IN2014KN02807A (enExample) 2015-05-08
CN104487823B (zh) 2017-02-22
BR112014029107A8 (pt) 2020-09-24
CA2874077A1 (en) 2013-11-28
CN104487823A (zh) 2015-04-01
BR112014029107B1 (pt) 2021-07-13
JP2015523556A (ja) 2015-08-13
US20150129766A1 (en) 2015-05-14
EP2852828B1 (en) 2016-04-06
ES2574614T3 (es) 2016-06-21
WO2013175312A1 (en) 2013-11-28
EP2852828A1 (en) 2015-04-01

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