HRP20240014T1 - Hplc-bazirana detekcija sredstava za flokulaciju u uzorku proteina - Google Patents

Hplc-bazirana detekcija sredstava za flokulaciju u uzorku proteina Download PDF

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Publication number
HRP20240014T1
HRP20240014T1 HRP20240014TT HRP20240014T HRP20240014T1 HR P20240014 T1 HRP20240014 T1 HR P20240014T1 HR P20240014T T HRP20240014T T HR P20240014TT HR P20240014 T HRP20240014 T HR P20240014T HR P20240014 T1 HRP20240014 T1 HR P20240014T1
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HR
Croatia
Prior art keywords
sample
pdadmac
cad
acid
hplc
Prior art date
Application number
HRP20240014TT
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English (en)
Inventor
Annick GERVAIS
Joel DUBISY
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UCB Biopharma SRL
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Application filed by UCB Biopharma SRL filed Critical UCB Biopharma SRL
Publication of HRP20240014T1 publication Critical patent/HRP20240014T1/hr

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/10Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166Fluid composition conditioning, e.g. gradient
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/32Bonded phase chromatography
    • B01D15/325Reversed phase
    • B01D15/327Reversed phase with hydrophobic interaction
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/28Control of physical parameters of the fluid carrier
    • G01N30/34Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins

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  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (10)

1. Postupak za mjerenje pDADMAC u uzorku koji sadrži rekombinantni protein od interesa, te postupak obuhvaća sljedeće korake: a) primjenu uzorka na HPLC hidrofobne interakcije reverzne faze, b) eluiranje vezanog pDADMAC iz kolone korištenjem hidrofobnog gradijenta eluiranja, c) mjerenje pDADMAC dobivenog u koraku b) pomoću detektora nabijenog aerosola (CAD), naznačen time što uzorak primijenjen u a) sadrži 0,2-3% (v/v) CAD-kompatibilne kiseline.
2. Postupak prema zahtjevu 1, naznačen time što uzorak primijenjen u koraku a) sadrži koncentraciju proteina manju od 200 mg/ml, kao što je 20-100 mg/ml, npr. 20-60 mg/ml.
3. Postupak prema zahtjevu 1 ili 2, naznačen time što uzorak primijenjen u koraku a) ima pH od 2 do 4.
4. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što uzorak primijenjen u koraku a) sadrži 0,5-1,5% (v/v) CAD-kompatibilne kiseline.
5. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što je navedena CAD-kompatibilna kiselina odabrana od trifluoroctene kiseline, octene kiseline, heptafluormaslačne kiseline i mravlje kiseline.
6. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što HPLC hidrofobne interakcije reverzne faze je PLRP-S HPLC.
7. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što postupak nadalje obuhvaća korak određivanja koncentracije pDADMAC prisutnog u uzorku usporedbom s kontrolom.
8. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što je rekombinantni protein od interesa protutijelo, fragment protutijela ili njegov derivat.
9. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što je uzorak primijenjen u koraku a) uzorak dobiven izravno iz koraka u pročišćavanju navedenog rekombinantnog proteina kojem je dodana CAD-kompatibilna kiselina.
10. Postupak proizvodnje proteina od interesa koji uključuje dodavanje pDADMAC tijekom pročišćavanja proteina, naznačen time što se naknadno uklanjanje navedenog pDADMAC mjeri postupkom prema bilo kojem od zahtjeva 1 do 9.
HRP20240014TT 2019-06-20 2020-06-18 Hplc-bazirana detekcija sredstava za flokulaciju u uzorku proteina HRP20240014T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP19181523 2019-06-20
PCT/EP2020/066922 WO2020254483A1 (en) 2019-06-20 2020-06-18 Hplc-based detection of flocculation agents in a protein sample
EP20733284.2A EP3986588B1 (en) 2019-06-20 2020-06-18 Hplc-based detection of flocculation agents in a protein sample

Publications (1)

Publication Number Publication Date
HRP20240014T1 true HRP20240014T1 (hr) 2024-03-29

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HRP20240014TT HRP20240014T1 (hr) 2019-06-20 2020-06-18 Hplc-bazirana detekcija sredstava za flokulaciju u uzorku proteina

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US (1) US20220241701A1 (hr)
EP (1) EP3986588B1 (hr)
JP (1) JP2022537297A (hr)
KR (1) KR20220024577A (hr)
CN (1) CN113924153B (hr)
AR (1) AR120062A1 (hr)
AU (1) AU2020294922A1 (hr)
BR (1) BR112021021212A2 (hr)
CA (1) CA3138832A1 (hr)
DK (1) DK3986588T3 (hr)
FI (1) FI3986588T3 (hr)
HR (1) HRP20240014T1 (hr)
IL (1) IL289021A (hr)
LT (1) LT3986588T (hr)
MX (1) MX2021015831A (hr)
PL (1) PL3986588T3 (hr)
PT (1) PT3986588T (hr)
SG (1) SG11202112000YA (hr)
SI (1) SI3986588T1 (hr)
WO (1) WO2020254483A1 (hr)

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EP4236099A1 (en) 2022-02-24 2023-08-30 Samsung Electronics Co., Ltd. Apparatus and method for channel sounding

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Publication number Priority date Publication date Assignee Title
CN1007906B (zh) * 1983-11-28 1990-05-09 武田药品工业株式会社 高纯度蛋白质的制备及其应用
US6673629B2 (en) * 1998-01-15 2004-01-06 Abbott Laboratories Neutralization of polycations in a chromatographic device for whole blood use
ES2361925T3 (es) * 2000-08-25 2011-06-24 Basf Plant Science Gmbh Polinucleótidos de plantas que codifican prenil proteasas.
EP2358734A1 (en) * 2008-12-16 2011-08-24 Millipore Corporation Purification of proteins
CN103120864B (zh) * 2013-03-06 2015-04-08 苏州环球色谱有限责任公司 一种石墨烯修饰毛细管色谱柱的制备方法
CA2924821A1 (en) * 2013-09-20 2015-03-26 Davuluri, Ramamohan Rao Purification of organic compounds by surfactant mediated preparative hplc
GB201411320D0 (en) 2014-06-25 2014-08-06 Ucb Biopharma Sprl Antibody construct
KR102450255B1 (ko) * 2016-05-25 2022-10-04 론자 휴스턴 아이엔씨. 폴리디알릴 디알킬암모늄 염을 이용한 아데노-관련 바이러스의 분리방법
US10927145B2 (en) * 2016-06-15 2021-02-23 Agency For Science, Technology And Research Method of enhancing the performance of chromatography methods for purification of proteins

Also Published As

Publication number Publication date
BR112021021212A2 (pt) 2021-12-28
CN113924153B (zh) 2023-08-01
SI3986588T1 (sl) 2024-03-29
EP3986588B1 (en) 2023-11-08
DK3986588T3 (da) 2024-01-15
FI3986588T3 (fi) 2024-01-19
SG11202112000YA (en) 2021-11-29
US20220241701A1 (en) 2022-08-04
PL3986588T3 (pl) 2024-04-08
MX2021015831A (es) 2022-02-03
CN113924153A (zh) 2022-01-11
KR20220024577A (ko) 2022-03-03
LT3986588T (lt) 2024-02-12
AU2020294922A1 (en) 2021-11-18
CA3138832A1 (en) 2020-12-24
IL289021A (en) 2022-02-01
PT3986588T (pt) 2024-01-18
AR120062A1 (es) 2022-02-02
WO2020254483A1 (en) 2020-12-24
JP2022537297A (ja) 2022-08-25
EP3986588A1 (en) 2022-04-27

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