EA202191931A1 - Способ характеризации видимых и/или невидимых частиц в биологических препаратах - Google Patents
Способ характеризации видимых и/или невидимых частиц в биологических препаратахInfo
- Publication number
- EA202191931A1 EA202191931A1 EA202191931A EA202191931A EA202191931A1 EA 202191931 A1 EA202191931 A1 EA 202191931A1 EA 202191931 A EA202191931 A EA 202191931A EA 202191931 A EA202191931 A EA 202191931A EA 202191931 A1 EA202191931 A1 EA 202191931A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- visible
- characterizing
- biological preparations
- invisible
- invisible particles
- Prior art date
Links
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6854—Immunoglobulins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6848—Methods of protein analysis involving mass spectrometry
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- 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
- G01N21/65—Raman scattering
-
- 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
- G01N30/72—Mass spectrometers
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
- H01J49/00—Particle spectrometers or separator tubes
- H01J49/0027—Methods for using particle spectrometers
- H01J49/0031—Step by step routines describing the use of the apparatus
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01J—ELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
- H01J49/00—Particle spectrometers or separator tubes
- H01J49/02—Details
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2560/00—Chemical aspects of mass spectrometric analysis of biological material
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Computational Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Biophysics (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
- Investigating Or Analysing Materials By Optical Means (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Abstract
В данном изобретении предложен способ характеризации или количественного определения одного или более белков в видимых и/или невидимых частицах, образованных в образце, путем обнаружения по меньшей мере одной видимой или невидимой частицы в образце, выделения и захвата по меньшей мере одной видимой или невидимой частицы для определения присутствия белка и использование масс-спектрометра для характеризации белка.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962798750P | 2019-01-30 | 2019-01-30 | |
PCT/US2020/015699 WO2020160161A1 (en) | 2019-01-30 | 2020-01-29 | Method of characterization of visible and/or sub-visible particles in biologics |
Publications (1)
Publication Number | Publication Date |
---|---|
EA202191931A1 true EA202191931A1 (ru) | 2022-02-14 |
Family
ID=69846159
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA202191931A EA202191931A1 (ru) | 2019-01-30 | 2020-01-29 | Способ характеризации видимых и/или невидимых частиц в биологических препаратах |
Country Status (14)
Country | Link |
---|---|
US (3) | US11187707B2 (ru) |
EP (1) | EP3918340A1 (ru) |
JP (1) | JP7466553B2 (ru) |
KR (1) | KR20210121107A (ru) |
CN (1) | CN113454460B (ru) |
AU (1) | AU2020214797A1 (ru) |
BR (1) | BR112021013734A2 (ru) |
CA (1) | CA3126710A1 (ru) |
EA (1) | EA202191931A1 (ru) |
IL (1) | IL284885A (ru) |
MX (1) | MX2021009264A (ru) |
SG (1) | SG11202108031VA (ru) |
WO (1) | WO2020160161A1 (ru) |
ZA (1) | ZA202105176B (ru) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA3126710A1 (en) * | 2019-01-30 | 2020-08-06 | Regeneron Pharamaceuticals, Inc. | Method of characterization of visible and/or sub-visible particles in biologics |
WO2022209422A1 (ja) * | 2021-03-30 | 2022-10-06 | 富士フイルム株式会社 | 精製状態の推定方法 |
WO2024052440A1 (en) | 2022-09-09 | 2024-03-14 | F. Hoffmann-La Roche Ag | Inspection system and method for a closed medical container |
CN116563244B (zh) * | 2023-05-11 | 2024-04-23 | 中国食品药品检定研究院 | 一种亚可见颗粒质控方法、系统及设备 |
Family Cites Families (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4734362A (en) * | 1986-02-03 | 1988-03-29 | Cambridge Bioscience Corporation | Process for purifying recombinant proteins, and products thereof |
CN1262667C (zh) * | 1996-04-25 | 2006-07-05 | 詹尼康科学公司 | 利用颗粒标记物检测分析物 |
US6547828B2 (en) * | 2001-02-23 | 2003-04-15 | Smith & Nephew, Inc. | Cross-linked ultra-high molecular weight polyethylene for medical implant use |
US20050148098A1 (en) * | 2003-12-30 | 2005-07-07 | Xing Su | Methods for using raman spectroscopy to obtain a protein profile of a biological sample |
US20100216969A1 (en) * | 2005-06-27 | 2010-08-26 | Bionanophotnics A/S | Immobilisation of polypeptides by irradiation |
US20070134814A1 (en) * | 2005-12-09 | 2007-06-14 | Kajander E O | Methods and compositions for the detection of calcifying nano-particles, identification and quantification of associated proteins thereon, and correlation to disease |
EP1991694B1 (en) * | 2006-02-13 | 2016-04-13 | Fluidigm Canada Inc. | Element-tagged oligonucleotide gene expression analysis |
WO2008141230A1 (en) * | 2007-05-09 | 2008-11-20 | Lawrence Livermore National Security, Llc | Methods and systems for monitoring production of a target protein in a nanolipoprotein particle |
US8147735B2 (en) * | 2008-07-09 | 2012-04-03 | Eltron Research & Development, Inc. | Semipermeable polymers and method for producing same |
EP2802871B1 (en) * | 2012-01-11 | 2022-07-27 | Takeda Pharmaceutical Company Limited | Characterization of subvisible particles using a particle analyzer |
EP2929050A1 (en) * | 2012-12-10 | 2015-10-14 | AdvanDx, Inc. | Use of probes for mass spectrometric identification of microorganisms or cells and associated conditions of interest |
TWI670279B (zh) * | 2013-03-15 | 2019-09-01 | 美商艾爾德生物製藥股份有限公司 | 抗體純化及純度監測 |
CA2910065C (en) * | 2013-05-15 | 2023-09-19 | Medimmune Limited | Purification of recombinantly produced polypeptides |
JP6400086B2 (ja) * | 2013-06-05 | 2018-10-03 | ディーエイチ テクノロジーズ デベロップメント プライベート リミテッド | バイオ医薬品タンパク質製品における宿主細胞タンパク質夾雑物の検出のためのswathデータ独立取得テクノロジ |
JP6687618B2 (ja) * | 2014-08-15 | 2020-04-22 | メディミューン,エルエルシー | 組換えタンパク質調製物中の残留宿主細胞タンパク質の検出 |
EP3218479A1 (en) * | 2014-11-11 | 2017-09-20 | Nanocore ApS | Method for identification of molecules with desired characteristics |
CN108026164A (zh) * | 2015-09-24 | 2018-05-11 | 梅约医学教育与研究基金会 | 通过质谱鉴定免疫球蛋白游离轻链 |
EP3427024A4 (en) * | 2016-02-18 | 2019-11-06 | Optofluidics, Inc. | SYSTEM AND METHOD FOR CHARACTERIZING PARTICLES IN A LIQUID SAMPLE |
TWI760345B (zh) * | 2016-07-05 | 2022-04-11 | 法商賽諾菲公司 | 抗體調配物 |
US11390840B2 (en) * | 2016-09-30 | 2022-07-19 | University Of Florida Research Foundation, Inc. | Systems and methods including porous membrane for low-voltage continuous cell electroporation |
WO2018213331A1 (en) * | 2017-05-16 | 2018-11-22 | Lankenau Institute For Medical Research | Compositions comprising ligands to rhob protein and the uses thereof |
CA3126710A1 (en) * | 2019-01-30 | 2020-08-06 | Regeneron Pharamaceuticals, Inc. | Method of characterization of visible and/or sub-visible particles in biologics |
-
2020
- 2020-01-29 CA CA3126710A patent/CA3126710A1/en active Pending
- 2020-01-29 BR BR112021013734-3A patent/BR112021013734A2/pt unknown
- 2020-01-29 JP JP2021544299A patent/JP7466553B2/ja active Active
- 2020-01-29 KR KR1020217026589A patent/KR20210121107A/ko unknown
- 2020-01-29 WO PCT/US2020/015699 patent/WO2020160161A1/en unknown
- 2020-01-29 MX MX2021009264A patent/MX2021009264A/es unknown
- 2020-01-29 SG SG11202108031VA patent/SG11202108031VA/en unknown
- 2020-01-29 EA EA202191931A patent/EA202191931A1/ru unknown
- 2020-01-29 EP EP20712416.5A patent/EP3918340A1/en active Pending
- 2020-01-29 CN CN202080009547.1A patent/CN113454460B/zh active Active
- 2020-01-29 AU AU2020214797A patent/AU2020214797A1/en active Pending
- 2020-01-29 US US16/776,187 patent/US11187707B2/en active Active
-
2021
- 2021-07-15 IL IL284885A patent/IL284885A/en unknown
- 2021-07-22 ZA ZA2021/05176A patent/ZA202105176B/en unknown
- 2021-10-19 US US17/505,389 patent/US11693010B2/en active Active
-
2023
- 2023-05-08 US US18/144,463 patent/US20230273219A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20230273219A1 (en) | 2023-08-31 |
US11187707B2 (en) | 2021-11-30 |
KR20210121107A (ko) | 2021-10-07 |
BR112021013734A2 (pt) | 2021-09-21 |
SG11202108031VA (en) | 2021-08-30 |
AU2020214797A1 (en) | 2021-08-12 |
US20200241002A1 (en) | 2020-07-30 |
ZA202105176B (en) | 2023-10-25 |
CA3126710A1 (en) | 2020-08-06 |
IL284885A (en) | 2021-08-31 |
CN113454460A (zh) | 2021-09-28 |
MX2021009264A (es) | 2021-08-24 |
JP2022519226A (ja) | 2022-03-22 |
WO2020160161A1 (en) | 2020-08-06 |
US11693010B2 (en) | 2023-07-04 |
EP3918340A1 (en) | 2021-12-08 |
CN113454460B (zh) | 2024-06-11 |
US20220034905A1 (en) | 2022-02-03 |
JP7466553B2 (ja) | 2024-04-12 |
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