JP5879357B2 - ガードカラムを備えるクロマトグラフィーシステム - Google Patents
ガードカラムを備えるクロマトグラフィーシステム Download PDFInfo
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- JP5879357B2 JP5879357B2 JP2013536561A JP2013536561A JP5879357B2 JP 5879357 B2 JP5879357 B2 JP 5879357B2 JP 2013536561 A JP2013536561 A JP 2013536561A JP 2013536561 A JP2013536561 A JP 2013536561A JP 5879357 B2 JP5879357 B2 JP 5879357B2
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- 238000004587 chromatography analysis Methods 0.000 title claims description 22
- 239000007788 liquid Substances 0.000 claims description 21
- 239000013076 target substance Substances 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 18
- 239000002699 waste material Substances 0.000 claims description 16
- 239000012530 fluid Substances 0.000 claims description 12
- 238000010828 elution Methods 0.000 claims description 11
- 239000003446 ligand Substances 0.000 claims description 11
- 238000013375 chromatographic separation Methods 0.000 claims description 7
- 238000005406 washing Methods 0.000 claims description 7
- 239000012539 chromatography resin Substances 0.000 claims description 6
- 238000011049 filling Methods 0.000 claims description 5
- 239000000126 substance Substances 0.000 claims description 5
- 238000012856 packing Methods 0.000 claims description 3
- 102000018071 Immunoglobulin Fc Fragments Human genes 0.000 claims description 2
- 108010091135 Immunoglobulin Fc Fragments Proteins 0.000 claims description 2
- 238000010521 absorption reaction Methods 0.000 claims description 2
- 239000011344 liquid material Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 238000001514 detection method Methods 0.000 claims 1
- 239000011347 resin Substances 0.000 description 22
- 229920005989 resin Polymers 0.000 description 22
- 230000008901 benefit Effects 0.000 description 15
- 239000002245 particle Substances 0.000 description 9
- 108090000623 proteins and genes Proteins 0.000 description 8
- 102000004169 proteins and genes Human genes 0.000 description 8
- 239000003480 eluent Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 239000013077 target material Substances 0.000 description 4
- 239000012501 chromatography medium Substances 0.000 description 3
- 238000004440 column chromatography Methods 0.000 description 3
- 229920006395 saturated elastomer Polymers 0.000 description 3
- 238000000926 separation method Methods 0.000 description 3
- 239000011358 absorbing material Substances 0.000 description 2
- 229960000074 biopharmaceutical Drugs 0.000 description 2
- 238000011210 chromatographic step Methods 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 230000000737 periodic effect Effects 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 1
- 229920002684 Sepharose Polymers 0.000 description 1
- 108010003723 Single-Domain Antibodies Proteins 0.000 description 1
- 101710120037 Toxin CcdB Proteins 0.000 description 1
- -1 and the like Substances 0.000 description 1
- 238000005571 anion exchange chromatography Methods 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 239000013060 biological fluid Substances 0.000 description 1
- 238000005277 cation exchange chromatography Methods 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000011437 continuous method Methods 0.000 description 1
- 238000004185 countercurrent chromatography Methods 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000011143 downstream manufacturing Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012527 feed solution Substances 0.000 description 1
- 238000000855 fermentation Methods 0.000 description 1
- 230000004151 fermentation Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000010353 genetic engineering Methods 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 230000004941 influx Effects 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000012516 mab select resin Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 238000012433 multimodal chromatography Methods 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 238000011137 process chromatography Methods 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000012562 protein A resin Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/38—Flow patterns
- G01N30/46—Flow patterns using more than one column
- G01N30/461—Flow patterns using more than one column with serial coupling of separation columns
-
- 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
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
- B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
- B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
- B01D15/1871—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns placed in series
-
- 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
- B01D15/3804—Affinity chromatography
- B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
- G01N2030/8813—Integrated 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
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- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
- Peptides Or Proteins (AREA)
Description
Claims (9)
- クロマトグラフィー樹脂を含むメインカラム(1)と、第1のガードカラム(2)と、第2のガードカラム(3)とを備えるクロマトグラフィーシステムであって、前記第1のガードカラム(2)は前記メインカラム(1)の第1の端部(4)に接続され、前記第2のガードカラム(3)は前記メインカラムの第2の端部(5)に接続され、第1の濃度検出器(6)は、前記メインカラム(1)の前記第1の端部(4)と前記第1のガードカラム(2)の間に接続され、第2の濃度検出器(7)は前記メインカラム(1)の前記第2の端部(5)と前記第2のガードカラム(3)の間に接続され、前記第1及び第2の濃度検出器(6、7)が任意には紫外線吸収検出器である、クロマトグラフィーシステム。
- 前記第1及び第2の濃度検出器に電気接続され、前記メインカラムの一端部(4、5)に与えられる供給液材料の組成を示している供給液信号、及び前記メインカラムの他端部(5、4)からの溶出液を示している溶出液信号を検出する決定ユニット(18)をさらに備える、請求項1記載のクロマトグラフィーシステム。
- 前記第1のガードカラム(2)は、供給液タンク(8)又は廃棄物レセプタクル(9)のいずれかに第1のバルブ(10)を介して接続され、前記第2のガードカラム(3)は、供給液タンク(15)又は廃棄物レセプタクル(16)のいずれかに第2のバルブ(17)を介して接続されるが、但し、前記第1のガードカラムが供給液タンクに接続される場合、前記第2のガードカラムは廃棄物レセプタクルに接続され、前記第1のガードカラムが廃棄物レセプタクルに接続される場合、前記第2のガードカラムは供給液タンクに接続される、請求項1又は請求項2記載のクロマトグラフィーシステム。
- 決定ユニット(18)は、前記第1及び第2のバルブに電気接続され、前記第1及び第2のバルブの位置を制御する、請求項3記載のクロマトグラフィーシステム。
- 前記メインカラム及び前記第1及び第2のガードカラムは、Fc断片結合親和性リガンドを備えるクロマトグラフィー樹脂を含む、請求項1乃至請求項4のいずれか1項記載のクロマトグラフィーシステム。
- 目標物質のクロマトグラフィー分離方法であって、
a)供給液を供給液タンク(8)から第1のガードカラム(2)を介してメインカラム(1)及び第2のガードカラム(3)を通して廃棄物レセプタクル(16)に運ぶことによって、メインカラム(1)上に前記目標物質を充填する段階と、
b)洗浄流体を前記第1のガードカラム(2)を介して前記メインカラム(1)及び前記第2のガードカラム(3)を通して運ぶことによって、前記カラムを洗浄する段階と、
c)溶出流体を前記第1のガードカラム(2)又は前記第2のガードカラム(3)を介して前記メインカラム(1)を通して、溶出液タンク(11、13)に運ぶことによって、前記目標物質を溶出させる段階と、任意段階として、
d)供給液を供給液タンク(15)から前記第2のガードカラム(3)を介して前記メインカラム(1)及び前記第1のガードカラム(2)を通して廃棄物レセプタクル(9)に運ぶことによって、前記メインカラム(1)上に前記目標物質を充填する段階と
を含む方法。 - 段階a)はさらに、前記メインカラムから出る前記流体内の目標物質の濃度を測定する段階と、前記濃度が所定の値に到達した場合に段階a)を終了させる段階とを含む、請求項6記載の方法。
- 段階a)はさらに、前記メインカラムの漏出点又は飽和点を決定する段階と、前記漏出点又は飽和点に到達した場合に段階a)を終了させる段階とを含む、請求項6又は請求項7記載の方法。
- 段階b)はさらに、前記メインカラムから出る前記流体内の目標物質の濃度を測定する段階と、前記濃度が所定の値より低い場合に段階b)を終了させる段階とを含む、請求項6乃至請求項8のいずれか1項記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE1051116-0 | 2010-10-27 | ||
SE1051116 | 2010-10-27 | ||
PCT/SE2011/051254 WO2012057676A1 (en) | 2010-10-27 | 2011-10-24 | Chromatography system with guard columns |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2014501911A JP2014501911A (ja) | 2014-01-23 |
JP2014501911A5 JP2014501911A5 (ja) | 2014-12-11 |
JP5879357B2 true JP5879357B2 (ja) | 2016-03-08 |
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Application Number | Title | Priority Date | Filing Date |
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JP2013536561A Active JP5879357B2 (ja) | 2010-10-27 | 2011-10-24 | ガードカラムを備えるクロマトグラフィーシステム |
Country Status (5)
Country | Link |
---|---|
US (3) | US20130213884A1 (ja) |
EP (1) | EP2633306B1 (ja) |
JP (1) | JP5879357B2 (ja) |
CN (1) | CN103180727B (ja) |
WO (1) | WO2012057676A1 (ja) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102014010353A1 (de) * | 2014-07-10 | 2016-01-14 | Sartorius Stedim Biotech Gmbh | Vorrichtung, Verwendung dieser Vorrichtung und Verfahren für die Stofftrennung mit verbesserter Ausnutzung der Kapazität chromatographischer Medien |
GB201511463D0 (en) | 2015-06-30 | 2015-08-12 | Ge Healthcare Bio Sciences Ab | Improvements in and relating to fluid path networks |
US11835501B2 (en) * | 2015-07-13 | 2023-12-05 | Sartorius Stedim Chromatography Systems Ltd. | Optimizing operating binding capacity for a multiple column chromatography process |
GB201517282D0 (en) * | 2015-09-30 | 2015-11-11 | Ge Healthcare Bio Sciences Ab | A chromatography system and a method therefor |
JP6206468B2 (ja) * | 2015-11-11 | 2017-10-04 | ダイキン工業株式会社 | スクロール圧縮機 |
GB201602938D0 (en) * | 2016-02-19 | 2016-04-06 | Ucb Biopharma Sprl | Protein purification |
WO2020037182A1 (en) * | 2018-08-17 | 2020-02-20 | Regeneron Pharmaceuticals, Inc. | Method and chromatography system for determining amount and purity of a multimeric protein |
GB201909274D0 (en) * | 2019-06-27 | 2019-08-14 | Ge Healthcare Bio Sciences Ab | Method in bioprocess purification system |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS60142251A (ja) * | 1983-12-29 | 1985-07-27 | Shimadzu Corp | ガ−ドカラム充てん法 |
US4826603A (en) * | 1986-09-09 | 1989-05-02 | United States Of America As Represented By The Secretary Of The Air Force | Hydrocarbon group-type analyzer system |
US4851355A (en) * | 1987-06-05 | 1989-07-25 | Hayes Jr Paul C | Hydrocarbon group-type analyzer system |
CN2094745U (zh) * | 1991-06-22 | 1992-01-29 | 中国科学院大连化学物理研究所 | 一种带保护柱的高效液相色谱柱 |
JP3053131B2 (ja) * | 1991-09-17 | 2000-06-19 | 株式会社日立製作所 | ガードカラムを備えた高速液体クロマトグラフ |
US5651885A (en) * | 1994-04-15 | 1997-07-29 | Schick; Hans G. | Column for liquid chromatography |
DE69627333T2 (de) * | 1995-06-26 | 2004-02-12 | PerSeptive Biosystems, Inc., Framingham | Automatisierte, kontinuierliche mehrdimensionale hochgeschwindigkeitsmolekularselektion und -analyse |
DE10049079A1 (de) * | 2000-10-02 | 2002-04-18 | Merck Patent Gmbh | Verfahren und System zur Methodenoptimierung in der Chromatographie |
US7691645B2 (en) * | 2001-01-09 | 2010-04-06 | Agilent Technologies, Inc. | Immunosubtraction method |
JP3996550B2 (ja) * | 2003-05-28 | 2007-10-24 | 株式会社日立ハイテクノロジーズ | アミノ酸分析装置 |
JP4504721B2 (ja) * | 2004-04-07 | 2010-07-14 | オルガノ株式会社 | 液体クロマトグラフィー装置 |
US20060157647A1 (en) * | 2005-01-18 | 2006-07-20 | Becton, Dickinson And Company | Multidimensional liquid chromatography/spectrometry |
US7520920B1 (en) * | 2005-03-04 | 2009-04-21 | Griffin Analytical Technologies | Guard columns for gas chromatographs and gas chromatograph-mass spectrometers |
CN106422418B (zh) * | 2006-09-29 | 2022-03-01 | 思拓凡生物工艺研发有限公司 | 用于抗体分离的包含来自金黄色葡萄球菌a蛋白的结构域c的层析配体 |
WO2009023268A1 (en) * | 2007-08-16 | 2009-02-19 | Alltech Associates Inc. | Chromatography column assemblies |
-
2011
- 2011-10-24 US US13/881,801 patent/US20130213884A1/en not_active Abandoned
- 2011-10-24 CN CN201180051833.5A patent/CN103180727B/zh active Active
- 2011-10-24 EP EP11836717.6A patent/EP2633306B1/en active Active
- 2011-10-24 JP JP2013536561A patent/JP5879357B2/ja active Active
- 2011-10-24 WO PCT/SE2011/051254 patent/WO2012057676A1/en active Application Filing
-
2018
- 2018-08-06 US US16/056,339 patent/US20180340917A1/en not_active Abandoned
-
2020
- 2020-11-24 US US17/102,865 patent/US20210080434A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
JP2014501911A (ja) | 2014-01-23 |
CN103180727A (zh) | 2013-06-26 |
EP2633306A1 (en) | 2013-09-04 |
US20180340917A1 (en) | 2018-11-29 |
US20130213884A1 (en) | 2013-08-22 |
CN103180727B (zh) | 2015-12-16 |
US20210080434A1 (en) | 2021-03-18 |
EP2633306A4 (en) | 2014-10-08 |
WO2012057676A1 (en) | 2012-05-03 |
EP2633306B1 (en) | 2016-03-23 |
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