JP2015523556A5 - - Google Patents
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- Publication number
- JP2015523556A5 JP2015523556A5 JP2015513294A JP2015513294A JP2015523556A5 JP 2015523556 A5 JP2015523556 A5 JP 2015523556A5 JP 2015513294 A JP2015513294 A JP 2015513294A JP 2015513294 A JP2015513294 A JP 2015513294A JP 2015523556 A5 JP2015523556 A5 JP 2015523556A5
- Authority
- JP
- Japan
- Prior art keywords
- protein
- polysorbate
- test sample
- species
- mixture
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
- 108090000623 proteins and genes Proteins 0.000 claims description 48
- 102000004169 proteins and genes Human genes 0.000 claims description 48
- 238000000034 method Methods 0.000 claims description 42
- 239000000203 mixture Substances 0.000 claims description 26
- 229920000136 polysorbate Polymers 0.000 claims description 17
- 229950008882 polysorbate Drugs 0.000 claims description 17
- 150000004676 glycans Chemical class 0.000 claims description 15
- 229920001282 polysaccharide Polymers 0.000 claims description 15
- 239000005017 polysaccharide Substances 0.000 claims description 15
- 238000001228 spectrum Methods 0.000 claims description 15
- 238000005102 attenuated total reflection Methods 0.000 claims description 11
- 241000894007 species Species 0.000 claims description 10
- 102000036639 antigens Human genes 0.000 claims description 7
- 108091007433 antigens Proteins 0.000 claims description 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 5
- 229920000053 polysorbate 80 Polymers 0.000 claims description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 4
- 241000701022 Cytomegalovirus Species 0.000 claims description 4
- IELOKBJPULMYRW-NJQVLOCASA-N D-alpha-Tocopheryl Acid Succinate Chemical compound OC(=O)CCC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C IELOKBJPULMYRW-NJQVLOCASA-N 0.000 claims description 4
- 241000606768 Haemophilus influenzae Species 0.000 claims description 4
- 101710154606 Hemagglutinin Proteins 0.000 claims description 4
- 241000701806 Human papillomavirus Species 0.000 claims description 4
- 241000712079 Measles morbillivirus Species 0.000 claims description 4
- 102000005348 Neuraminidase Human genes 0.000 claims description 4
- 108010006232 Neuraminidase Proteins 0.000 claims description 4
- 101710093908 Outer capsid protein VP4 Proteins 0.000 claims description 4
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 4
- 101710176177 Protein A56 Proteins 0.000 claims description 4
- 241000725643 Respiratory syncytial virus Species 0.000 claims description 4
- 239000000427 antigen Substances 0.000 claims description 4
- 229940099418 d- alpha-tocopherol succinate Drugs 0.000 claims description 4
- 239000000185 hemagglutinin Substances 0.000 claims description 4
- 206010022000 influenza Diseases 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims description 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 4
- 229940068968 polysorbate 80 Drugs 0.000 claims description 4
- -1 1,1,3,3-tetramethylbutyl Chemical group 0.000 claims description 3
- 241000293871 Salmonella enterica subsp. enterica serovar Typhi Species 0.000 claims description 3
- 150000001540 azides Chemical class 0.000 claims description 3
- ODWNBAWYDSWOAF-UHFFFAOYSA-N 2,4,4-trimethylpentan-2-yloxybenzene Chemical compound CC(C)(C)CC(C)(C)OC1=CC=CC=C1 ODWNBAWYDSWOAF-UHFFFAOYSA-N 0.000 claims description 2
- 238000004483 ATR-FTIR spectroscopy Methods 0.000 claims description 2
- 241000588807 Bordetella Species 0.000 claims description 2
- 241000588832 Bordetella pertussis Species 0.000 claims description 2
- 201000006082 Chickenpox Diseases 0.000 claims description 2
- 241000193403 Clostridium Species 0.000 claims description 2
- 241000193449 Clostridium tetani Species 0.000 claims description 2
- 241000186216 Corynebacterium Species 0.000 claims description 2
- 241000725619 Dengue virus Species 0.000 claims description 2
- 241000991587 Enterovirus C Species 0.000 claims description 2
- 208000000666 Fowlpox Diseases 0.000 claims description 2
- 241000700721 Hepatitis B virus Species 0.000 claims description 2
- 241000709721 Hepatovirus A Species 0.000 claims description 2
- 201000009906 Meningitis Diseases 0.000 claims description 2
- 241000711386 Mumps virus Species 0.000 claims description 2
- 241000588653 Neisseria Species 0.000 claims description 2
- 241000710799 Rubella virus Species 0.000 claims description 2
- 241000607142 Salmonella Species 0.000 claims description 2
- 241000194017 Streptococcus Species 0.000 claims description 2
- 201000005010 Streptococcus pneumonia Diseases 0.000 claims description 2
- 241000193998 Streptococcus pneumoniae Species 0.000 claims description 2
- 206010046980 Varicella Diseases 0.000 claims description 2
- 241000700647 Variola virus Species 0.000 claims description 2
- 108010067390 Viral Proteins Proteins 0.000 claims description 2
- 241000700605 Viruses Species 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 238000011088 calibration curve Methods 0.000 claims description 2
- 206010013023 diphtheria Diseases 0.000 claims description 2
- 229940045808 haemophilus influenzae type b Drugs 0.000 claims description 2
- 108700010900 influenza virus proteins Proteins 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 229910052757 nitrogen Inorganic materials 0.000 claims description 2
- 229920002114 octoxynol-9 Polymers 0.000 claims description 2
- 108700010850 rotavirus proteins Proteins 0.000 claims description 2
- 241001529453 unidentified herpesvirus Species 0.000 claims description 2
- 229940124856 vaccine component Drugs 0.000 claims description 2
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 238000011018 current good manufacturing practice Methods 0.000 description 2
- 238000005033 Fourier transform infrared spectroscopy Methods 0.000 description 1
- 238000004566 IR spectroscopy Methods 0.000 description 1
- 229920001213 Polysorbate 20 Polymers 0.000 description 1
- 229920001219 Polysorbate 40 Polymers 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- IVRMZWNICZWHMI-UHFFFAOYSA-N azide group Chemical group [N-]=[N+]=[N-] IVRMZWNICZWHMI-UHFFFAOYSA-N 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 229960003971 influenza vaccine Drugs 0.000 description 1
- 239000004530 micro-emulsion Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940101027 polysorbate 40 Drugs 0.000 description 1
- 229940113124 polysorbate 60 Drugs 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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 (3)
| Publication Number | Publication Date |
|---|---|
| JP2015523556A JP2015523556A (ja) | 2015-08-13 |
| JP2015523556A5 true JP2015523556A5 (enExample) | 2016-06-09 |
| JP6129302B2 JP6129302B2 (ja) | 2017-05-17 |
Family
ID=48916129
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015513294A Active JP6129302B2 (ja) | 2012-05-23 | 2013-05-21 | 混合物中のポリソルベート種の濃度を決定するための方法 |
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) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN109716127B (zh) * | 2016-08-15 | 2022-06-14 | 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 |
| WO2019002295A1 (en) * | 2017-06-27 | 2019-01-03 | Coriolis Pharma Research GmbH | QUANTITATIVE DETERMINATION OF POLYSORBATE |
| US11946865B2 (en) * | 2018-06-28 | 2024-04-02 | Becton, Dickinson And Company | Systems and methods for normalizing signals in blood culture measurement systems |
| WO2020002342A1 (en) * | 2018-06-29 | 2020-01-02 | 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 |
| US10845248B1 (en) | 2019-05-01 | 2020-11-24 | 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 |
| IL296330A (en) * | 2020-03-20 | 2022-11-01 | Glaxosmithkline Ip Dev Ltd | 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 |
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6040191A (en) * | 1996-06-13 | 2000-03-21 | Grow; Ann E. | Raman spectroscopic method for determining the ligand binding capacity of biologicals |
| US5866430A (en) * | 1996-06-13 | 1999-02-02 | Grow; Ann E. | Raman optrode processes and devices for detection of chemicals and microorganisms |
| WO2002086492A1 (en) * | 2001-04-17 | 2002-10-31 | Chugai Seiyaku Kabushiki Kaisha | Method of quantifying surfactant |
| WO2003085422A2 (en) | 2001-09-04 | 2003-10-16 | North Carolina State University | Single pass attenuated total reflection infrared analysis 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 |
-
2013
- 2013-05-21 CN CN201380026314.2A patent/CN104487823B/zh active Active
- 2013-05-21 BR BR112014029107-1A patent/BR112014029107B1/pt active IP Right Grant
- 2013-05-21 EP EP13745180.3A patent/EP2852828B1/en active Active
- 2013-05-21 CA CA2874077A patent/CA2874077C/en active Active
- 2013-05-21 WO PCT/IB2013/001590 patent/WO2013175312A1/en not_active Ceased
- 2013-05-21 US US14/402,849 patent/US9134228B2/en active Active
- 2013-05-21 ES ES13745180.3T patent/ES2574614T3/es active Active
- 2013-05-21 IN IN2807KON2014 patent/IN2014KN02807A/en unknown
- 2013-05-21 JP JP2015513294A patent/JP6129302B2/ja active Active
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