RU2013118019A - Очистка антител с помощью хроматографии с псевдодвижущимся слоем - Google Patents
Очистка антител с помощью хроматографии с псевдодвижущимся слоем Download PDFInfo
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- C07K1/18—Ion-exchange chromatography
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- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
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- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/65—Raman scattering
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- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/32—Bonded phase chromatography
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
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Abstract
1. Способ получения препарата белка, являющегося целью выделения, с уменьшенным содержанием белка клетки-хозяина (HCP) из образца смеси, содержащей белок, являющийся целью выделения, и, по меньшей мере, один HCP, где указанный способ содержит:(a) проведение анализа Рамановской спектроскопии указанного образца смеси;(b) приведение указанного образца смеси в контакт с хроматографической смолой так, что смола нагружена до приблизительно 50-100% насыщения ее связующей способности; и(с) сбор хроматографического образца; и(d) проведение анализа Рамановской спектроскопии указанного хроматографического образца для идентификации его как препарата, являющегося целью выделения, с уменьшенным HCP.2. Способ по п.1, где хроматографическая смола выбрана из группы, состоящей из аффинной хроматографической смолы, ионообменной хроматографической смолы и хроматографической смолы гидрофобного взаимодействия.3. Способ по п.1, где белок, являющийся целью выделения, выбран из группы, состоящей из: ферментов; пептидных гормонов; поликлональных антител; моноклональных антител человека; гуманизированных моноклональных антител; химерных моноклональных антител; одноцепочечных антител; Fab-фрагментов антитела; F(ab')2-фрагментов антитела; Fd-фрагментов антитела; Fv-фрагментов антитела; выделенных CDR; диател и иммуноадгезивных веществ.4. Способ по п.1, где хроматографическая смола упакована в серию жидкостно связанных колонок, разделенных жидкостными трубопроводами, содержащими входные и выходные клапаны, причем число жидкостно соединенных колонок выбрано из группы, состоящей из 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 и 12 колонок.5. Способ по п.1, где образец смеси приводят в
Claims (7)
1. Способ получения препарата белка, являющегося целью выделения, с уменьшенным содержанием белка клетки-хозяина (HCP) из образца смеси, содержащей белок, являющийся целью выделения, и, по меньшей мере, один HCP, где указанный способ содержит:
(a) проведение анализа Рамановской спектроскопии указанного образца смеси;
(b) приведение указанного образца смеси в контакт с хроматографической смолой так, что смола нагружена до приблизительно 50-100% насыщения ее связующей способности; и
(с) сбор хроматографического образца; и
(d) проведение анализа Рамановской спектроскопии указанного хроматографического образца для идентификации его как препарата, являющегося целью выделения, с уменьшенным HCP.
2. Способ по п.1, где хроматографическая смола выбрана из группы, состоящей из аффинной хроматографической смолы, ионообменной хроматографической смолы и хроматографической смолы гидрофобного взаимодействия.
3. Способ по п.1, где белок, являющийся целью выделения, выбран из группы, состоящей из: ферментов; пептидных гормонов; поликлональных антител; моноклональных антител человека; гуманизированных моноклональных антител; химерных моноклональных антител; одноцепочечных антител; Fab-фрагментов антитела; F(ab')2-фрагментов антитела; Fd-фрагментов антитела; Fv-фрагментов антитела; выделенных CDR; диател и иммуноадгезивных веществ.
4. Способ по п.1, где хроматографическая смола упакована в серию жидкостно связанных колонок, разделенных жидкостными трубопроводами, содержащими входные и выходные клапаны, причем число жидкостно соединенных колонок выбрано из группы, состоящей из 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 и 12 колонок.
5. Способ по п.1, где образец смеси приводят в контакт с хроматографической смолой так, чтобы получить время удерживания, выбранное из группы, состоящей из до приблизительно 0,5, до приблизительно 1, до приблизительно 2, до приблизительно 3, до приблизительно 4, до приблизительно 5, до приблизительно 6, до приблизительно 7, до приблизительно 8, до приблизительно 9, до приблизительно 10, до приблизительно 11 и до приблизительно 12 мин.
6. Способ по п.1, дополнительно содержащий стадии уравновешивания хроматографической смолы перед приведением в контакт с образцом смеси и отмывку хроматографической смолы после приведения в контакт с образцом смеси, причем буферы уравновешивания и отмывки являются идентичными буферами.
7. Способ по п.1, дополнительно содержащий стадии отмывки, элюции и регенерации хроматографической смолы, где такие стадии могут быть рассчитаны и запрограммированы так, чтобы поддерживать длительность стадии приведения в контакт образца с хроматографической смолой от приблизительно 20 до приблизительно 80% от времени процесса.
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US38462010P | 2010-09-20 | 2010-09-20 | |
US61/384,620 | 2010-09-20 | ||
PCT/US2011/051874 WO2012040041A1 (en) | 2010-09-20 | 2011-09-16 | Purification of antibodies using simulated moving bed chromatography |
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RU2013118019A true RU2013118019A (ru) | 2014-10-27 |
RU2608499C2 RU2608499C2 (ru) | 2017-01-18 |
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RU2013118019A RU2608499C2 (ru) | 2010-09-20 | 2011-09-16 | Очистка антител с помощью хроматографии с псевдодвижущимся слоем |
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US (1) | US20120122076A1 (ru) |
EP (1) | EP2618904A1 (ru) |
JP (1) | JP6010030B2 (ru) |
KR (1) | KR20130114143A (ru) |
CN (2) | CN105753933A (ru) |
AU (3) | AU2011305754B2 (ru) |
BR (1) | BR112013006403A2 (ru) |
CA (1) | CA2810909A1 (ru) |
MX (1) | MX2013003182A (ru) |
NZ (1) | NZ607750A (ru) |
RU (1) | RU2608499C2 (ru) |
SG (1) | SG188616A1 (ru) |
TW (1) | TWI617571B (ru) |
WO (1) | WO2012040041A1 (ru) |
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-
2011
- 2011-09-16 RU RU2013118019A patent/RU2608499C2/ru active
- 2011-09-16 JP JP2013529353A patent/JP6010030B2/ja active Active
- 2011-09-16 CN CN201610139672.XA patent/CN105753933A/zh active Pending
- 2011-09-16 NZ NZ60775011A patent/NZ607750A/en unknown
- 2011-09-16 CA CA2810909A patent/CA2810909A1/en not_active Abandoned
- 2011-09-16 SG SG2013020516A patent/SG188616A1/en unknown
- 2011-09-16 CN CN201180055293.8A patent/CN103201003B/zh active Active
- 2011-09-16 MX MX2013003182A patent/MX2013003182A/es unknown
- 2011-09-16 EP EP11761225.9A patent/EP2618904A1/en not_active Withdrawn
- 2011-09-16 BR BR112013006403A patent/BR112013006403A2/pt not_active Application Discontinuation
- 2011-09-16 AU AU2011305754A patent/AU2011305754B2/en active Active
- 2011-09-16 KR KR1020137009913A patent/KR20130114143A/ko not_active Application Discontinuation
- 2011-09-16 WO PCT/US2011/051874 patent/WO2012040041A1/en active Application Filing
- 2011-09-16 US US13/234,938 patent/US20120122076A1/en not_active Abandoned
- 2011-09-20 TW TW100133868A patent/TWI617571B/zh active
-
2016
- 2016-02-04 AU AU2016200716A patent/AU2016200716A1/en not_active Abandoned
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Publication number | Publication date |
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TW201305187A (zh) | 2013-02-01 |
AU2017248524A1 (en) | 2017-11-09 |
WO2012040041A1 (en) | 2012-03-29 |
KR20130114143A (ko) | 2013-10-16 |
AU2011305754A1 (en) | 2013-03-21 |
AU2011305754B2 (en) | 2015-11-05 |
CN103201003A (zh) | 2013-07-10 |
CN105753933A (zh) | 2016-07-13 |
EP2618904A1 (en) | 2013-07-31 |
BR112013006403A2 (pt) | 2015-09-29 |
MX2013003182A (es) | 2013-04-24 |
CN103201003B (zh) | 2016-04-13 |
RU2608499C2 (ru) | 2017-01-18 |
AU2016200716A1 (en) | 2016-02-25 |
US20120122076A1 (en) | 2012-05-17 |
TWI617571B (zh) | 2018-03-11 |
SG188616A1 (en) | 2013-04-30 |
NZ607750A (en) | 2015-03-27 |
JP2013537235A (ja) | 2013-09-30 |
CA2810909A1 (en) | 2012-03-29 |
JP6010030B2 (ja) | 2016-10-19 |
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