KR102408260B1 - 숙주 세포 단백질의 검출을 위한 조성물 및 방법 - Google Patents

숙주 세포 단백질의 검출을 위한 조성물 및 방법 Download PDF

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KR102408260B1
KR102408260B1 KR1020187032543A KR20187032543A KR102408260B1 KR 102408260 B1 KR102408260 B1 KR 102408260B1 KR 1020187032543 A KR1020187032543 A KR 1020187032543A KR 20187032543 A KR20187032543 A KR 20187032543A KR 102408260 B1 KR102408260 B1 KR 102408260B1
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궈지에 마오
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론자 리미티드
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature

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KR1020187032543A 2016-04-14 2017-04-12 숙주 세포 단백질의 검출을 위한 조성물 및 방법 Active KR102408260B1 (ko)

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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

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KR20180129927A KR20180129927A (ko) 2018-12-05
KR102408260B1 true KR102408260B1 (ko) 2022-06-10

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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)

* Cited by examiner, † Cited by third party
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005071410A1 (en) 2004-01-13 2005-08-04 Tanox, Inc. Detecting and quantifying host cell proteins in recombinant protein products
WO2015038888A1 (en) 2013-09-13 2015-03-19 Genentech, Inc. Methods and compositions comprising purified recombinant polypeptides

Family Cites Families (22)

* Cited by examiner, † Cited by third party
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
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
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005071410A1 (en) 2004-01-13 2005-08-04 Tanox, Inc. Detecting and quantifying host cell proteins in recombinant protein products
WO2015038888A1 (en) 2013-09-13 2015-03-19 Genentech, Inc. Methods and compositions comprising purified recombinant polypeptides

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Catherine EM Hogwood et al, Current Opinion in Biotechnology (2014), vol 30, pp 153-160.
Zhu shimoni J et al, Biotechnology and Bioengineering (2014), vol 111, no 12, pp 2367-2379.

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EP3683579A1 (en) 2020-07-22
CA3020808A1 (en) 2017-10-19
US20220268791A1 (en) 2022-08-25
IL262297A (en) 2018-11-29
SG11201808992UA (en) 2018-11-29
US11353468B2 (en) 2022-06-07
EA201892325A1 (ru) 2019-04-30
US20190128903A1 (en) 2019-05-02
EP3443348A1 (en) 2019-02-20
WO2017178526A1 (en) 2017-10-19
CN109564217A (zh) 2019-04-02
KR20180129927A (ko) 2018-12-05
IL290358A (en) 2022-04-01
AU2017251360A1 (en) 2018-11-01
IL290358B1 (en) 2023-11-01
US12203948B2 (en) 2025-01-21
ES2994760T3 (en) 2025-01-30
MX2018012550A (es) 2019-07-08
IL290358B2 (en) 2024-03-01
BR112018071107A2 (pt) 2019-04-16
JP7565147B2 (ja) 2024-10-10
EP3683579B1 (en) 2024-10-23
JP2019516964A (ja) 2019-06-20
CN115109148A (zh) 2022-09-27
US20220268792A1 (en) 2022-08-25
EP3683579C0 (en) 2024-10-23

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