RU2638913C2 - Системы и способы для обнаружения частиц в полезном агенте - Google Patents

Системы и способы для обнаружения частиц в полезном агенте Download PDF

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RU2638913C2
RU2638913C2 RU2014152326A RU2014152326A RU2638913C2 RU 2638913 C2 RU2638913 C2 RU 2638913C2 RU 2014152326 A RU2014152326 A RU 2014152326A RU 2014152326 A RU2014152326 A RU 2014152326A RU 2638913 C2 RU2638913 C2 RU 2638913C2
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image
beneficial agent
liquid beneficial
particles
intensity
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RU2014152326A
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English (en)
Russian (ru)
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RU2014152326A (ru
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Эдмунд МАТАЙОСИ
Цзе ВАН
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Эббви Инк.
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/02Investigating particle size or size distribution
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/06Investigating concentration of particle suspensions
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/10Investigating individual particles
    • G01N15/14Optical investigation techniques, e.g. flow cytometry
    • G01N15/1434Optical arrangements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/49Scattering, i.e. diffuse reflection within a body or fluid
    • G01N21/51Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/645Specially adapted constructive features of fluorimeters
    • G01N21/6456Spatial resolved fluorescence measurements; Imaging
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/90Investigating the presence of flaws or contamination in a container or its contents
    • G01N21/9018Dirt detection in containers
    • G01N21/9027Dirt detection in containers in containers after filling
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
    • G01N15/06Investigating concentration of particle suspensions
    • G01N15/075Investigating concentration of particle suspensions by optical means

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Food Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
RU2014152326A 2012-05-24 2013-05-23 Системы и способы для обнаружения частиц в полезном агенте RU2638913C2 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261651211P 2012-05-24 2012-05-24
US61/651,211 2012-05-24
US13/841,143 US10132736B2 (en) 2012-05-24 2013-03-15 Methods for inspection of protein particles in a liquid beneficial agent
US13/841,143 2013-03-15
PCT/US2013/042481 WO2013177434A2 (en) 2012-05-24 2013-05-23 Systems and methods for detection of particles in a beneficial agent

Publications (2)

Publication Number Publication Date
RU2014152326A RU2014152326A (ru) 2016-07-20
RU2638913C2 true RU2638913C2 (ru) 2017-12-18

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RU2014152326A RU2638913C2 (ru) 2012-05-24 2013-05-23 Системы и способы для обнаружения частиц в полезном агенте

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US (2) US10132736B2 (enExample)
EP (2) EP3835753A3 (enExample)
JP (1) JP2015517677A (enExample)
CN (1) CN104487816A (enExample)
CA (1) CA2873671A1 (enExample)
IN (1) IN2014DN09753A (enExample)
MX (1) MX337973B (enExample)
NZ (1) NZ631595A (enExample)
RU (1) RU2638913C2 (enExample)
SG (1) SG11201407660SA (enExample)
WO (1) WO2013177434A2 (enExample)
ZA (1) ZA201408386B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU213288U1 (ru) * 2021-02-14 2022-09-05 Общество С Ограниченной Ответственностью "Нп Вижн" Оптический измеритель численной концентрации наночастиц

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI840888B (zh) 2011-08-29 2024-05-01 美商安美基公司 用於非破壞性檢測-流體中未溶解粒子之方法及裝置
JP6247743B2 (ja) * 2013-04-22 2017-12-13 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 注射デバイスに取り付けるための補助デバイス
GB2539504B (en) 2015-06-19 2019-04-17 Aqua21 Ltd Absorption Sensor for Measuring Substance Concentration
EP3350574B1 (en) * 2015-09-16 2021-12-15 Thermo Electron Scientific Instruments LLC Image analysis system and method
WO2017200939A1 (en) 2016-05-16 2017-11-23 Abbvie Inc. Systems and methods for identifying protein aggregates in biotherapeutics
DE102016012585A1 (de) * 2016-10-21 2018-04-26 Seidenader Maschinenbau Gmbh Vorrichtung zur Detektion von Luftblasen in einem mit Flüssigkeit befüllten Behälter
CN110023950B (zh) * 2016-10-28 2023-08-08 拜克门寇尔特公司 物质准备评估系统
CN106772975B (zh) * 2017-01-19 2019-08-13 宁波纳美致生物科技有限公司 针对细胞或组织不同深度超分辨率显微成像的照明系统
JP2020524123A (ja) * 2017-05-31 2020-08-13 ニプロ株式会社 ガラス容器の評価方法
EP3688446A2 (en) * 2017-09-29 2020-08-05 Apple Inc. Resolve path optical sampling architectures
SG11202007756XA (en) * 2018-03-30 2020-09-29 Amgen Inc Camera-based drug container inspection
JP7116419B2 (ja) * 2018-10-04 2022-08-10 国立研究開発法人産業技術総合研究所 粒子測定装置、較正方法、および測定装置
WO2020131666A1 (en) 2018-12-17 2020-06-25 Amgen Inc. Sheet lighting for particle detection in drug product containers
CN109883905A (zh) * 2019-03-07 2019-06-14 南京理工大学 水下粒径在线测量系统及方法
WO2021173604A1 (en) * 2020-02-24 2021-09-02 Des-Case Corporation Apparatuses, systems, and methods for providing a smart liquid information indicator
CN112730174A (zh) * 2020-12-17 2021-04-30 华南理工大学 一种实时监测结晶过程中类球形颗粒浓度的方法
WO2022168434A1 (ja) * 2021-02-05 2022-08-11 株式会社堀場製作所 粒子分析装置、粒子分析方法、及び、粒子分析装置用プログラム
JP7281500B2 (ja) * 2021-05-17 2023-05-25 東亜建設工業株式会社 画像データの取得方法および取得システム
US20230394696A1 (en) * 2022-06-02 2023-12-07 University Of Central Florida Research Foundation, Inc. Systems and methods for image-based characterization of fluid in an enclosed container
TWI863605B (zh) * 2023-10-03 2024-11-21 住華科技股份有限公司 溶液的粒子濃度分佈的檢測方法
DE102025101336A1 (de) 2024-01-19 2025-07-24 Abbvie Inc. Zusammensetzungen von clostridium botulinum neurotoxin serotyp a und verbesserte trocknungsprozesse

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5674410A (en) * 1993-07-20 1997-10-07 Dainippon Screen Manufacturing Co., Ltd. Chemical agent producing device and method thereof
WO2005099408A2 (en) * 2004-04-10 2005-10-27 Michael Trainer Methods and apparatus for determining particle characterics by measuring scattered light

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3627423A (en) 1970-02-17 1971-12-14 Schering Corp Method and apparatus for detecting particular matter in sealed liquids
US3713743A (en) 1970-11-25 1973-01-30 Agricultural Control Syst Forward scatter optical turbidimeter apparatus
US3830969A (en) 1971-10-14 1974-08-20 Princeton Electronic Prod System for detecting particulate matter
FR2276581A1 (fr) 1974-06-27 1976-01-23 Kolikovitcher Irene Appareil pour le controle d'ampoules pharmaceutiques
JPS56104233A (en) * 1980-01-25 1981-08-19 Kanebo Ltd Counter for microscopic object in liquid
US4814868A (en) 1987-10-02 1989-03-21 Quadtek, Inc. Apparatus and method for imaging and counting moving particles
JPH01308942A (ja) 1988-06-08 1989-12-13 Mitsubishi Electric Corp 固体表面付着微粒子計数装置
JPH03156370A (ja) 1989-11-15 1991-07-04 Hitachi Ltd 免疫測定方法および装置
US5269937A (en) 1990-10-23 1993-12-14 Cetus Corporation HPLC light scattering detector for biopolymers
JPH0720049A (ja) * 1993-07-05 1995-01-24 Nippondenso Co Ltd 液体性状検出装置
US5835211A (en) 1996-03-28 1998-11-10 Particle Sizing Systems, Inc. Single-particle optical sensor with improved sensitivity and dynamic size range
JP3731700B2 (ja) 1997-12-25 2006-01-05 興和株式会社 蛍光粒子撮像装置
CA2439307A1 (en) * 2001-02-23 2002-09-06 Genicon Sciences Corporation Methods for providing extended dynamic range in analyte assays
US7430047B2 (en) * 2004-03-09 2008-09-30 Gerald Walter Budd Small container fluid dynamics to produce optimized inspection conditions
EP1630550A1 (en) * 2004-08-27 2006-03-01 Moller & Devicon A/S Methods and apparatuses of detecting foreign particles or faults in a plurality of filled containers
TW200806317A (en) 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
US9417176B2 (en) 2007-01-19 2016-08-16 Tudor Arvinte Method and apparatus for detecting and registering properties of samples
EP2232231A4 (en) 2007-12-04 2015-12-02 Particle Measuring Syst SYSTEMS AND METHODS FOR DETECTION OF NON-ORTHOGONAL PARTICLES
CN107121396B (zh) * 2008-09-24 2020-06-30 曙光生命科学公司 用于检测分析物的方法
NZ706187A (en) * 2009-10-26 2016-09-30 Nestec Sa Assays for the detection of anti-tnf drugs and autoantibodies
JP5330317B2 (ja) 2010-06-02 2013-10-30 株式会社日立ハイテクノロジーズ 生体試料の分析方法および分析装置
FR2963103B1 (fr) 2010-07-22 2012-08-24 Commissariat Energie Atomique Procede d'estimation de la quantite d'entites deposees sur des microparticules en suspension dans une solution, dispositif associe et utilisation de ce dispositif
US8405033B2 (en) 2010-07-30 2013-03-26 Buglab Llc Optical sensor for rapid determination of particulate concentration
TWI840888B (zh) 2011-08-29 2024-05-01 美商安美基公司 用於非破壞性檢測-流體中未溶解粒子之方法及裝置
DE102011084583A1 (de) 2011-10-17 2013-04-18 Zf Friedrichshafen Ag Betätigungseinrichtung zum Betätigen von Schaltelementen

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5674410A (en) * 1993-07-20 1997-10-07 Dainippon Screen Manufacturing Co., Ltd. Chemical agent producing device and method thereof
WO2005099408A2 (en) * 2004-04-10 2005-10-27 Michael Trainer Methods and apparatus for determining particle characterics by measuring scattered light

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU213288U1 (ru) * 2021-02-14 2022-09-05 Общество С Ограниченной Ответственностью "Нп Вижн" Оптический измеритель численной концентрации наночастиц

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Publication number Publication date
SG11201407660SA (en) 2014-12-30
EP3835753A2 (en) 2021-06-16
US20130316934A1 (en) 2013-11-28
WO2013177434A3 (en) 2014-01-30
MX337973B (es) 2016-03-29
US10126226B2 (en) 2018-11-13
US10132736B2 (en) 2018-11-20
IN2014DN09753A (enExample) 2015-07-31
NZ631595A (en) 2016-05-27
US20150226659A1 (en) 2015-08-13
CN104487816A (zh) 2015-04-01
EP3835753A3 (en) 2021-09-22
RU2014152326A (ru) 2016-07-20
MX2014014340A (es) 2015-03-03
CA2873671A1 (en) 2013-11-28
ZA201408386B (en) 2015-11-25
WO2013177434A2 (en) 2013-11-28
JP2015517677A (ja) 2015-06-22
EP2856106A2 (en) 2015-04-08

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Effective date: 20190524