WO2020227126A1 - Détermination de contaminants dans des produits à base de cellules à l'aide de microscopie à imagerie de flux - Google Patents
Détermination de contaminants dans des produits à base de cellules à l'aide de microscopie à imagerie de flux Download PDFInfo
- Publication number
- WO2020227126A1 WO2020227126A1 PCT/US2020/031106 US2020031106W WO2020227126A1 WO 2020227126 A1 WO2020227126 A1 WO 2020227126A1 US 2020031106 W US2020031106 W US 2020031106W WO 2020227126 A1 WO2020227126 A1 WO 2020227126A1
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- WO
- WIPO (PCT)
- Prior art keywords
- cell
- cells
- sub
- images
- based suspension
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- 238000012059 flow imaging microscopy Methods 0.000 title claims abstract description 22
- 239000000356 contaminant Substances 0.000 title description 18
- 238000000034 method Methods 0.000 claims abstract description 57
- 239000000725 suspension Substances 0.000 claims abstract description 55
- 239000012906 subvisible particle Substances 0.000 claims abstract description 51
- 210000004027 cell Anatomy 0.000 claims description 137
- 239000002245 particle Substances 0.000 claims description 52
- 229920002545 silicone oil Polymers 0.000 claims description 19
- 239000011521 glass Substances 0.000 claims description 16
- 229920001971 elastomer Polymers 0.000 claims description 12
- 238000003384 imaging method Methods 0.000 claims description 12
- 230000001413 cellular effect Effects 0.000 claims description 10
- 239000004033 plastic Substances 0.000 claims description 10
- 229920003023 plastic Polymers 0.000 claims description 10
- 238000005516 engineering process Methods 0.000 claims description 8
- 206010029260 Neuroblastoma Diseases 0.000 claims description 4
- 210000004698 lymphocyte Anatomy 0.000 claims description 4
- 210000000130 stem cell Anatomy 0.000 claims description 4
- 210000004443 dendritic cell Anatomy 0.000 claims description 3
- 210000003958 hematopoietic stem cell Anatomy 0.000 claims description 3
- 210000000663 muscle cell Anatomy 0.000 claims description 3
- 239000006285 cell suspension Substances 0.000 description 15
- 238000012538 light obscuration Methods 0.000 description 14
- 239000012535 impurity Substances 0.000 description 13
- 238000002659 cell therapy Methods 0.000 description 10
- 238000012512 characterization method Methods 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000005259 measurement Methods 0.000 description 5
- 238000012008 microflow imaging Methods 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 238000005299 abrasion Methods 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 239000006144 Dulbecco’s modified Eagle's medium Substances 0.000 description 3
- 210000000601 blood cell Anatomy 0.000 description 3
- -1 cellular debris Substances 0.000 description 3
- 238000011109 contamination Methods 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
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- 238000002156 mixing Methods 0.000 description 3
- 230000000877 morphologic effect Effects 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 229920002379 silicone rubber Polymers 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 108091003079 Bovine Serum Albumin Proteins 0.000 description 2
- 230000024245 cell differentiation Effects 0.000 description 2
- 238000011217 control strategy Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940126534 drug product Drugs 0.000 description 2
- 239000003797 essential amino acid Substances 0.000 description 2
- 235000020776 essential amino acid Nutrition 0.000 description 2
- 239000012091 fetal bovine serum Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000011194 good manufacturing practice Methods 0.000 description 2
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- 238000012552 review Methods 0.000 description 2
- UCSJYZPVAKXKNQ-HZYVHMACSA-N streptomycin Chemical compound CN[C@H]1[C@H](O)[C@@H](O)[C@H](CO)O[C@H]1O[C@@H]1[C@](C=O)(O)[C@H](C)O[C@H]1O[C@@H]1[C@@H](NC(N)=N)[C@H](O)[C@@H](NC(N)=N)[C@H](O)[C@H]1O UCSJYZPVAKXKNQ-HZYVHMACSA-N 0.000 description 2
- 229960005322 streptomycin Drugs 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
- 238000012356 Product development Methods 0.000 description 1
- LCTONWCANYUPML-UHFFFAOYSA-M Pyruvate Chemical compound CC(=O)C([O-])=O LCTONWCANYUPML-UHFFFAOYSA-M 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 210000004504 adult stem cell Anatomy 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
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- 210000003651 basophil Anatomy 0.000 description 1
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- 238000004113 cell culture Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000004163 cytometry Methods 0.000 description 1
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- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 210000001671 embryonic stem cell Anatomy 0.000 description 1
- 210000003979 eosinophil Anatomy 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 210000003714 granulocyte Anatomy 0.000 description 1
- 238000003306 harvesting Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 210000004263 induced pluripotent stem cell Anatomy 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000001616 monocyte Anatomy 0.000 description 1
- 210000000440 neutrophil Anatomy 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 238000012503 pharmacopoeial method Methods 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 210000001778 pluripotent stem cell Anatomy 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000011165 process development Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 229940043263 traditional drug Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 230000035899 viability Effects 0.000 description 1
- 239000012905 visible particle Substances 0.000 description 1
- 238000012431 visual particle testing Methods 0.000 description 1
- 238000003260 vortexing Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/10—Investigating individual particles
- G01N15/14—Optical investigation techniques, e.g. flow cytometry
- G01N15/1468—Optical investigation techniques, e.g. flow cytometry with spatial resolution of the texture or inner structure of the particle
- G01N15/147—Optical investigation techniques, e.g. flow cytometry with spatial resolution of the texture or inner structure of the particle the analysis being performed on a sample stream
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N2015/0038—Investigating nanoparticles
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
- G01N15/10—Investigating individual particles
- G01N2015/1006—Investigating individual particles for cytology
Landscapes
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
La présente invention concerne un procédé de caractérisation de sous-particules visibles dans une suspension à base de cellules, le procédé consistant à soumettre la suspension à base de cellules à une microscopie à imagerie de flux, à collecter des images des sous-particules visibles dans la suspension à base de cellules et puis à caractériser les sous-particules visibles dans les images.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962843148P | 2019-05-03 | 2019-05-03 | |
| US62/843,148 | 2019-05-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2020227126A1 true WO2020227126A1 (fr) | 2020-11-12 |
Family
ID=73051333
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2020/031106 WO2020227126A1 (fr) | 2019-05-03 | 2020-05-01 | Détermination de contaminants dans des produits à base de cellules à l'aide de microscopie à imagerie de flux |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2020227126A1 (fr) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116563244A (zh) * | 2023-05-11 | 2023-08-08 | 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 |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160002285A1 (en) * | 2010-07-19 | 2016-01-07 | Barofold, Inc. | Therapeutic protein compositions having reduced immunogenicity and/or improved efficacy |
| US20160101181A1 (en) * | 2014-10-09 | 2016-04-14 | Regeneron Pharmaceuticals, Inc. | Process for reducing subvisible particles in a pharmaceutical formulation |
| WO2017143332A1 (fr) * | 2016-02-18 | 2017-08-24 | Optofluidics, Inc. | Système et procédé de caractérisation de particules dans un échantillon de fluide |
| US9842408B2 (en) * | 2011-08-29 | 2017-12-12 | Amgen Inc. | Methods and apparati for nondestructive detection of undissolved particles in a fluid |
| US20190083618A1 (en) * | 2017-09-19 | 2019-03-21 | Regeneron Pharmaceuticals, Inc. | Methods of reducing particle formation and compositions formed thereby |
| WO2020028313A1 (fr) * | 2018-07-31 | 2020-02-06 | The Regents Of The University Of Colorado A Body Corporate | Systèmes et procédés d'application d'apprentissage automatique pour analyser des images de microcopie dans des systèmes à haut débit |
-
2020
- 2020-05-01 WO PCT/US2020/031106 patent/WO2020227126A1/fr active Application Filing
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160002285A1 (en) * | 2010-07-19 | 2016-01-07 | Barofold, Inc. | Therapeutic protein compositions having reduced immunogenicity and/or improved efficacy |
| US9842408B2 (en) * | 2011-08-29 | 2017-12-12 | Amgen Inc. | Methods and apparati for nondestructive detection of undissolved particles in a fluid |
| US20160101181A1 (en) * | 2014-10-09 | 2016-04-14 | Regeneron Pharmaceuticals, Inc. | Process for reducing subvisible particles in a pharmaceutical formulation |
| WO2017143332A1 (fr) * | 2016-02-18 | 2017-08-24 | Optofluidics, Inc. | Système et procédé de caractérisation de particules dans un échantillon de fluide |
| US20190083618A1 (en) * | 2017-09-19 | 2019-03-21 | Regeneron Pharmaceuticals, Inc. | Methods of reducing particle formation and compositions formed thereby |
| WO2020028313A1 (fr) * | 2018-07-31 | 2020-02-06 | The Regents Of The University Of Colorado A Body Corporate | Systèmes et procédés d'application d'apprentissage automatique pour analyser des images de microcopie dans des systèmes à haut débit |
Non-Patent Citations (2)
| Title |
|---|
| SEDIQ ET AL.: "Label-Free, Flow-Imaging Methods for Determination of Cell Concentration and Viability", PHARMACEUTICAL RESEARCH, vol. 35, no. 8, 30 May 2018 (2018-05-30), pages 1 - 10, XP036542909, DOI: 10.1007/s11095-018-2422-5 * |
| VOLLRATH ILONA, MATHAES ROMAN, SEDIQ AHMAD S., JERE DHANANJAY, JÖRG SUSANNE, HUWYLER JÖRG, MAHLER HANNS-CHRISTIAN: "Subvisible Particulate Contamination in Cell Therapy Products - Can We Distinguish?", JOURNAL OF PHARMACEUTICAL SCIENCE, vol. 109, no. 1, January 2020 (2020-01-01), pages 216 - 219, XP055759843, DOI: 10.1016/j.xphs.2019.09.002 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116563244A (zh) * | 2023-05-11 | 2023-08-08 | 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 |
| 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 |
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