DK3349872T3 - Fremgangsmåde til kvantificering af renhed af subvisible partikelprøver - Google Patents

Fremgangsmåde til kvantificering af renhed af subvisible partikelprøver Download PDF

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Publication number
DK3349872T3
DK3349872T3 DK17857181.6T DK17857181T DK3349872T3 DK 3349872 T3 DK3349872 T3 DK 3349872T3 DK 17857181 T DK17857181 T DK 17857181T DK 3349872 T3 DK3349872 T3 DK 3349872T3
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DK
Denmark
Prior art keywords
procedure
particle samples
subvisible particle
quantifying
purity
Prior art date
Application number
DK17857181.6T
Other languages
English (en)
Inventor
Ida-Maria Sintorn
Martin Ryner
Gustaf Kylberg
Josefina Nilsson
Original Assignee
Intelligent Virus Imaging 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 Intelligent Virus Imaging Inc filed Critical Intelligent Virus Imaging Inc
Application granted granted Critical
Publication of DK3349872T3 publication Critical patent/DK3349872T3/da

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01BMEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B21/00Measuring arrangements or details thereof, where the measuring technique is not covered by the other groups of this subclass, unspecified or not relevant
    • G01B21/28Measuring arrangements or details thereof, where the measuring technique is not covered by the other groups of this subclass, unspecified or not relevant for measuring areas
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01BMEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B15/00Measuring arrangements characterised by the use of electromagnetic waves or particle radiation, e.g. by the use of microwaves, X-rays, gamma rays or electrons
    • 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
    • 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
    • G01N15/1429Signal processing
    • G01N15/1433Signal processing using image recognition
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N23/00Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00
    • G01N23/02Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00 by transmitting the radiation through the material
    • G01N23/04Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups G01N3/00 – G01N17/00, G01N21/00 or G01N22/00 by transmitting the radiation through the material and forming images of the material
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06VIMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
    • G06V10/00Arrangements for image or video recognition or understanding
    • G06V10/40Extraction of image or video features
    • G06V10/44Local feature extraction by analysis of parts of the pattern, e.g. by detecting edges, contours, loops, corners, strokes or intersections; Connectivity analysis, e.g. of connected components
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06VIMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
    • G06V20/00Scenes; Scene-specific elements
    • G06V20/60Type of objects
    • G06V20/69Microscopic objects, e.g. biological cells or cellular parts
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06VIMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
    • G06V20/00Scenes; Scene-specific elements
    • G06V20/60Type of objects
    • G06V20/69Microscopic objects, e.g. biological cells or cellular parts
    • G06V20/698Matching; Classification
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q2565/00Nucleic acid analysis characterised by mode or means of detection
    • C12Q2565/60Detection means characterised by use of a special device
    • C12Q2565/601Detection means characterised by use of a special device being a microscope, e.g. atomic force microscopy [AFM]
    • 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
    • G01N2015/0038Investigating nanoparticles
    • 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
    • G01N2015/1006Investigating individual particles for cytology
    • 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
    • G01N2015/103Particle shape
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2223/00Investigating materials by wave or particle radiation
    • G01N2223/40Imaging
    • G01N2223/401Imaging image processing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2223/00Investigating materials by wave or particle radiation
    • G01N2223/40Imaging
    • G01N2223/405Imaging mapping of a material property

Landscapes

  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Multimedia (AREA)
  • Theoretical Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Signal Processing (AREA)
  • Electromagnetism (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Analysing Materials By The Use Of Radiation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Image Analysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK17857181.6T 2016-09-30 2017-09-11 Fremgangsmåde til kvantificering af renhed af subvisible partikelprøver DK3349872T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662402003P 2016-09-30 2016-09-30
PCT/US2017/050962 WO2018063785A1 (en) 2016-09-30 2017-09-11 Method for quantification of purity of sub-visible particle samples

Publications (1)

Publication Number Publication Date
DK3349872T3 true DK3349872T3 (da) 2020-03-16

Family

ID=61762953

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17857181.6T DK3349872T3 (da) 2016-09-30 2017-09-11 Fremgangsmåde til kvantificering af renhed af subvisible partikelprøver

Country Status (24)

Country Link
US (2) US10451566B2 (da)
EP (1) EP3349872B1 (da)
JP (1) JP6790091B2 (da)
KR (1) KR102176815B1 (da)
CN (1) CN109715259B (da)
AU (1) AU2017335569B2 (da)
BR (1) BR112018012570A2 (da)
CA (1) CA2997325C (da)
CL (1) CL2018002522A1 (da)
DK (1) DK3349872T3 (da)
EA (1) EA036586B1 (da)
ES (1) ES2774533T3 (da)
HU (1) HUE048000T2 (da)
IL (1) IL259279B (da)
MA (1) MA42888B1 (da)
MX (1) MX2018012349A (da)
MY (1) MY193420A (da)
NZ (1) NZ741498A (da)
PL (1) PL3349872T3 (da)
PT (1) PT3349872T (da)
SA (1) SA519401436B1 (da)
SG (1) SG11201805521XA (da)
UA (1) UA125437C2 (da)
WO (1) WO2018063785A1 (da)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018063785A1 (en) * 2016-09-30 2018-04-05 Intelligent Virus Imaging Inc. Method for quantification of purity of sub-visible particle samples
KR102192033B1 (ko) * 2019-03-05 2020-12-16 서울대학교산학협력단 전자현미경 이미지 분석 방법
CN112697658B (zh) * 2019-10-23 2024-09-10 中国石油化工股份有限公司 存储器、电子显微镜颗粒几何性质测定方法、设备和装置
CN116563249A (zh) * 2023-05-11 2023-08-08 中国食品药品检定研究院 一种眼内注射剂的亚可见颗粒质控方法、系统及设备
CN116817804B (zh) * 2023-08-24 2023-11-03 江苏集创原子团簇科技研究院有限公司 一种多层石墨烯中离子注入深度精确标定方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5917927A (en) * 1997-03-21 1999-06-29 Satake Corporation Grain inspection and analysis apparatus and method
WO2003025858A2 (en) * 2001-09-17 2003-03-27 Her Majesty The Queen In Right Of Canada As Represented By The Minister Of Agriculture And Agri-Food Method for identifying and quantifying characteristics of seeds and other small objects
US8805039B2 (en) * 2005-10-12 2014-08-12 Intelligent Virus Imaging Inc Identification and classification of virus particles in textured electron micrographs
US8712141B2 (en) * 2007-05-30 2014-04-29 Intelligent Virus Imagaing Inc. Method for counting and segmenting viral particles in an image
BRPI0811951A2 (pt) * 2007-05-30 2016-10-04 Intelligent Virus Imagins Inc método de contagem e segmentação de partículas virais em uma imagem.
SE532499C2 (sv) * 2008-01-18 2010-02-09 Hemocue Ab Metod och apparat för analys av partiklar i ett vätskeformigt prov
JP2011095182A (ja) * 2009-10-30 2011-05-12 Sysmex Corp 細胞分析装置及び細胞分析方法
EP2335825A1 (en) * 2009-12-21 2011-06-22 F. Hoffmann-La Roche AG Unit and device for the preparation of cells and/or particles in a liquid and method for microscopic analysis
CN111610138B (zh) * 2011-04-15 2023-06-09 罗氏血液诊断股份有限公司 测量细胞体积和成份
WO2018063785A1 (en) * 2016-09-30 2018-04-05 Intelligent Virus Imaging Inc. Method for quantification of purity of sub-visible particle samples

Also Published As

Publication number Publication date
EA201890740A1 (ru) 2019-08-30
CA2997325A1 (en) 2018-03-30
EA036586B1 (ru) 2020-11-26
UA125437C2 (uk) 2022-03-09
ES2774533T3 (es) 2020-07-21
US10451566B2 (en) 2019-10-22
MA42888B1 (fr) 2020-03-31
PT3349872T (pt) 2020-03-13
WO2018063785A1 (en) 2018-04-05
CN109715259B (zh) 2021-02-26
HUE048000T2 (hu) 2020-05-28
MY193420A (en) 2022-10-12
JP6790091B2 (ja) 2020-11-25
JP2019532253A (ja) 2019-11-07
EP3349872A4 (en) 2019-06-26
NZ741498A (en) 2020-03-27
AU2017335569A1 (en) 2018-05-10
SA519401436B1 (ar) 2022-01-10
PL3349872T3 (pl) 2020-06-15
MX2018012349A (es) 2018-12-17
CN109715259A (zh) 2019-05-03
MA42888A1 (fr) 2018-11-30
KR102176815B1 (ko) 2020-11-10
KR20190039464A (ko) 2019-04-12
BR112018012570A2 (pt) 2018-12-04
EP3349872A1 (en) 2018-07-25
IL259279A (en) 2018-07-31
US20190376910A1 (en) 2019-12-12
CA2997325C (en) 2023-03-28
US11002689B2 (en) 2021-05-11
US20190011378A1 (en) 2019-01-10
SG11201805521XA (en) 2018-07-30
IL259279B (en) 2021-10-31
AU2017335569B2 (en) 2019-11-21
CL2018002522A1 (es) 2018-11-30
EP3349872B1 (en) 2019-12-11

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