JP2019516964A5 - - Google Patents
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- Publication number
- JP2019516964A5 JP2019516964A5 JP2018553973A JP2018553973A JP2019516964A5 JP 2019516964 A5 JP2019516964 A5 JP 2019516964A5 JP 2018553973 A JP2018553973 A JP 2018553973A JP 2018553973 A JP2018553973 A JP 2018553973A JP 2019516964 A5 JP2019516964 A5 JP 2019516964A5
- Authority
- JP
- Japan
- Prior art keywords
- hcp
- antibody
- sample
- recombinant polypeptide
- host cell
- 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
- 238000000034 method Methods 0.000 claims 19
- 229920001184 polypeptide Polymers 0.000 claims 8
- 108090000765 processed proteins & peptides Proteins 0.000 claims 8
- 102000004196 processed proteins & peptides Human genes 0.000 claims 8
- 210000004027 cell Anatomy 0.000 claims 7
- 238000002360 preparation method Methods 0.000 claims 7
- ATDGTVJJHBUTRL-UHFFFAOYSA-N cyanogen bromide Chemical compound BrC#N ATDGTVJJHBUTRL-UHFFFAOYSA-N 0.000 claims 4
- 108090000623 proteins and genes Proteins 0.000 claims 4
- 102000004169 proteins and genes Human genes 0.000 claims 4
- 239000000758 substrate Substances 0.000 claims 4
- 239000003153 chemical reaction reagent Substances 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 241001465754 Metazoa Species 0.000 claims 2
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 2
- 238000012544 monitoring process Methods 0.000 claims 2
- 108090001008 Avidin Proteins 0.000 claims 1
- 241000283707 Capra Species 0.000 claims 1
- NQTADLQHYWFPDB-UHFFFAOYSA-N N-Hydroxysuccinimide Chemical compound ON1C(=O)CCC1=O NQTADLQHYWFPDB-UHFFFAOYSA-N 0.000 claims 1
- 241001494479 Pecora Species 0.000 claims 1
- 230000000919 anti-host Effects 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 239000013256 coordination polymer Substances 0.000 claims 1
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 238000001514 detection method Methods 0.000 claims 1
- 238000011143 downstream manufacturing Methods 0.000 claims 1
- 239000012467 final product Substances 0.000 claims 1
- 238000011534 incubation Methods 0.000 claims 1
- 210000004962 mammalian cell Anatomy 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 238000011144 upstream manufacturing Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662322621P | 2016-04-14 | 2016-04-14 | |
| US62/322,621 | 2016-04-14 | ||
| PCT/EP2017/058775 WO2017178526A1 (en) | 2016-04-14 | 2017-04-12 | Compositions and methods for the detection of host cell proteins |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019516964A JP2019516964A (ja) | 2019-06-20 |
| JP2019516964A5 true JP2019516964A5 (enExample) | 2020-04-23 |
| JP7565147B2 JP7565147B2 (ja) | 2024-10-10 |
Family
ID=58645011
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018553973A Active JP7565147B2 (ja) | 2016-04-14 | 2017-04-12 | 宿主細胞タンパク質の検出のための組成物及び方法 |
Country Status (14)
| Country | Link |
|---|---|
| US (3) | US11353468B2 (enExample) |
| EP (2) | EP3443348A1 (enExample) |
| JP (1) | JP7565147B2 (enExample) |
| KR (1) | KR102408260B1 (enExample) |
| CN (2) | CN109564217A (enExample) |
| AU (1) | AU2017251360A1 (enExample) |
| BR (1) | BR112018071107A2 (enExample) |
| CA (1) | CA3020808A1 (enExample) |
| EA (1) | EA201892325A1 (enExample) |
| ES (1) | ES2994760T3 (enExample) |
| IL (2) | IL290358B2 (enExample) |
| MX (1) | MX2018012550A (enExample) |
| SG (1) | SG11201808992UA (enExample) |
| WO (1) | WO2017178526A1 (enExample) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL290358B2 (en) * | 2016-04-14 | 2024-03-01 | Lonza Ag | Preparations and methods for detecting host cell proteins |
| US11268951B2 (en) * | 2017-09-20 | 2022-03-08 | Charles River Laboratories International, Inc. | CHO host cell protein assay |
| CN109078628B (zh) * | 2018-08-27 | 2021-06-11 | 西北大学 | 一种以苄胺为配基的高效疏水相互作用色谱介质、制备方法及其在蛋白质复性与纯化的应用 |
| CN111665364B (zh) * | 2019-03-08 | 2025-01-21 | 湖州申科生物技术股份有限公司 | 一种评估hcp检测用多克隆抗体覆盖率的方法 |
| KR20220107586A (ko) | 2021-01-25 | 2022-08-02 | 금오공과대학교 산학협력단 | 전기신호를 이용한 세포수 검출장치 및 이를 이용한 검출방법 |
| CN114966038A (zh) * | 2022-04-13 | 2022-08-30 | 翌圣生物科技(上海)股份有限公司 | 精确定量检测生物医药制品中残留sp2/0宿主细胞蛋白的方法及ELISA检测试剂盒 |
| WO2024084264A1 (en) * | 2022-10-17 | 2024-04-25 | HAJIAN TEHRANI, Behrooz | Immunoassay for detecting host cell proteins of high five cells |
| CN115894677A (zh) * | 2022-12-01 | 2023-04-04 | 湖州申科生物技术股份有限公司 | 一种提高hcp检测抗体覆盖率的抗体组合及其应用 |
| CN117192107A (zh) * | 2023-09-11 | 2023-12-08 | 福建基诺厚普生物科技有限公司 | 一种工艺特异性宿主细胞蛋白残留的检测方法及试剂盒 |
| US20250334572A1 (en) * | 2024-04-26 | 2025-10-30 | Waters Technologies Corporation | Host cell protein detection using lateral flow devices |
| CN118465164B (zh) * | 2024-05-10 | 2025-02-14 | 上海澳斯康生物制药有限公司 | 一种用于检测hcp抗体覆盖率的方法及其应用 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3645090A (en) | 1969-06-19 | 1972-02-29 | Citizen Watch Co Ltd | Day-date quick-adjuster for calender timepiece |
| US3940475A (en) | 1970-06-11 | 1976-02-24 | Biological Developments, Inc. | Radioimmune method of assaying quantitatively for a hapten |
| US4737456A (en) | 1985-05-09 | 1988-04-12 | Syntex (U.S.A.) Inc. | Reducing interference in ligand-receptor binding assays |
| US5272071A (en) | 1989-12-22 | 1993-12-21 | Applied Research Systems Ars Holding N.V. | Method for the modification of the expression characteristics of an endogenous gene of a given cell line |
| GB9022545D0 (en) | 1990-10-17 | 1990-11-28 | Wellcome Found | Culture medium |
| US6797522B1 (en) * | 1994-01-13 | 2004-09-28 | The Trustees Of Columbia University In The City Of New York | Synthetic receptors |
| EP0985039B1 (en) | 1997-06-12 | 2008-02-20 | Novartis International Pharmaceutical Ltd. | Artificial antibody polypeptides |
| AU2199099A (en) * | 1997-12-31 | 1999-07-19 | Genentech Inc. | Real-time monitoring of an analyte by chromatography using an on-line assay |
| WO2001029058A1 (en) | 1999-10-15 | 2001-04-26 | University Of Massachusetts | Rna interference pathway genes as tools for targeted genetic interference |
| US6326193B1 (en) | 1999-11-05 | 2001-12-04 | Cambria Biosciences, Llc | Insect control agent |
| CN1321753A (zh) * | 2000-04-29 | 2001-11-14 | 上海博德基因开发有限公司 | 一种新的多肽——人b细胞蛋白酪氨酸激酶13和编码这种多肽的多核苷酸 |
| WO2001096584A2 (en) | 2000-06-12 | 2001-12-20 | Akkadix Corporation | Materials and methods for the control of nematodes |
| US20030091976A1 (en) * | 2001-11-14 | 2003-05-15 | Ciphergen Biosystems, Inc. | Methods for monitoring polypeptide production and purification using surface enhanced laser desorption/ionization mass spectrometry |
| US20060205010A1 (en) * | 2003-04-22 | 2006-09-14 | Catherine Allioux | Methods of host cell protein analysis |
| US20080261249A1 (en) * | 2004-01-13 | 2008-10-23 | Genentech, Inc | Detecting and Quantifying Host Cell Proteins in Recombinant Protein Products |
| US8728828B2 (en) * | 2004-12-22 | 2014-05-20 | Ge Healthcare Bio-Sciences Ab | Purification of immunoglobulins |
| CN101571549B (zh) * | 2008-04-30 | 2013-08-14 | 上海泽润生物科技有限公司 | Vero细胞HCP检测试剂盒及其应用 |
| NZ592095A (en) * | 2008-10-20 | 2013-01-25 | Abbott Lab | Isolation and purification of il-12 and tnf-alpha antibodies using protein a affinity chromatography |
| BR112015009553A2 (pt) | 2012-10-30 | 2017-10-03 | Hoffmann La Roche | Método para separar uma proteína de interesse de uma solução de cultura de células |
| CN103439512B (zh) * | 2013-07-30 | 2014-05-07 | 通化东宝药业股份有限公司 | 一种检测特异性重组人胰岛素大肠杆菌残留宿主蛋白的方法 |
| NZ756750A (en) | 2013-09-13 | 2022-05-27 | Genentech Inc | Methods and compositions comprising purified recombinant polypeptides |
| CN103792366B (zh) * | 2014-01-21 | 2015-09-23 | 内蒙古必威安泰生物科技有限公司 | 口蹄疫疫苗宿主细胞蛋白双抗夹心酶联免疫检测试剂盒及使用方法 |
| CN105021824A (zh) * | 2015-07-06 | 2015-11-04 | 上海优者生物科技有限公司 | 用于定量检测生物医药制品中残留cho宿主细胞蛋白的elisa试剂盒及其使用方法 |
| IL290358B2 (en) | 2016-04-14 | 2024-03-01 | Lonza Ag | Preparations and methods for detecting host cell proteins |
-
2017
- 2017-04-12 IL IL290358A patent/IL290358B2/en unknown
- 2017-04-12 KR KR1020187032543A patent/KR102408260B1/ko active Active
- 2017-04-12 BR BR112018071107-1A patent/BR112018071107A2/pt not_active Application Discontinuation
- 2017-04-12 US US16/093,253 patent/US11353468B2/en active Active
- 2017-04-12 ES ES20160929T patent/ES2994760T3/es active Active
- 2017-04-12 CA CA3020808A patent/CA3020808A1/en not_active Abandoned
- 2017-04-12 EP EP17720378.3A patent/EP3443348A1/en not_active Withdrawn
- 2017-04-12 SG SG11201808992UA patent/SG11201808992UA/en unknown
- 2017-04-12 EA EA201892325A patent/EA201892325A1/ru unknown
- 2017-04-12 CN CN201780034661.8A patent/CN109564217A/zh active Pending
- 2017-04-12 EP EP20160929.4A patent/EP3683579B1/en active Active
- 2017-04-12 JP JP2018553973A patent/JP7565147B2/ja active Active
- 2017-04-12 WO PCT/EP2017/058775 patent/WO2017178526A1/en not_active Ceased
- 2017-04-12 MX MX2018012550A patent/MX2018012550A/es unknown
- 2017-04-12 CN CN202210618930.8A patent/CN115109148A/zh active Pending
- 2017-04-12 AU AU2017251360A patent/AU2017251360A1/en not_active Abandoned
-
2018
- 2018-10-11 IL IL262297A patent/IL262297A/en unknown
-
2022
- 2022-05-03 US US17/735,555 patent/US20220268792A1/en active Pending
- 2022-05-03 US US17/735,524 patent/US12203948B2/en active Active
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