JP7012023B2 - タンパク質精製方法 - Google Patents
タンパク質精製方法 Download PDFInfo
- Publication number
- JP7012023B2 JP7012023B2 JP2018551087A JP2018551087A JP7012023B2 JP 7012023 B2 JP7012023 B2 JP 7012023B2 JP 2018551087 A JP2018551087 A JP 2018551087A JP 2018551087 A JP2018551087 A JP 2018551087A JP 7012023 B2 JP7012023 B2 JP 7012023B2
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- JP
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- Prior art keywords
- protein
- antibody
- chromatography
- filtration
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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
- B01D15/10—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
- B01D15/265—Adsorption chromatography
-
- 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
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/362—Cation-exchange
-
- 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
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
- B01J20/20—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising free carbon; comprising carbon obtained by carbonising processes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
- B01J20/281—Sorbents specially adapted for preparative, analytical or investigative chromatography
- B01J20/282—Porous sorbents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J47/00—Ion-exchange processes in general; Apparatus therefor
- B01J47/014—Ion-exchange processes in general; Apparatus therefor in which the adsorbent properties of the ion-exchanger are involved, e.g. recovery of proteins or other high-molecular compounds
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
Description
- 該抗体又はそのフラグメントを宿主細胞中で発現させること、
- 該抗体又はそのフラグメント、宿主細胞デブリ、及び不純物を含有する混合物を回収すること;並びに
- 該混合物から該抗体又はそのフラグメントを精製することを含み、該精製が、
- 活性炭素濾過と、それに続く
- プロテインAクロマトグラフィーと
を含む方法を提供する。
- 活性炭素濾過と、それに続く
- プロテインAクロマトグラフィーと
を含む方法を提供する。
- 活性炭素濾過と、それに続く
- プロテインAクロマトグラフィーと
を含む方法を提供する。
- 活性炭素濾過と、それに続く
- プロテインAクロマトグラフィーと
を含む方法を提供する。
2000L規模のバイオリアクタープロセスにおける抗体還元の防止
この例において、2000L規模における分子Aの製造は、プロテインA捕捉クロマトグラフィーステップ後に、キャンペーン2において顕著な抗体還元を示した。その後の製造キャンペーン(キャンペーン3)において、図3に描写するように最初の回収プロセスにおいて活性炭素濾過ステップを実装した(Millistak+CR40、Millipore)。このキャンペーンにおいて、抗体還元は検出されなかった。
400L規模のバイオリアクタープロセスにおける抗体還元の防止
この例において、400L規模における分子Bの製造は、プロテインA捕捉クロマトグラフィーステップ後に、キャンペーン1のバッチ1において顕著な抗体還元を示した。その後の製造バッチにおいて、図3に描写するように最初の回収プロセスにおいて活性炭素濾過ステップ(Millistak+CR40、Millipore)を実装した。これらのバッチにおいて、抗体還元は検出されなかった。
サンプルは、濾過後(炭素濾過有り及び無し)における分子Bの製造キャンペーンから採取されたが、その後、低酸素条件下で、規模を縮小したモデルの製造プロセスを使用して精製された。このモデルは、サンプルに窒素ガスを少なくとも30分間にわたって注入することを含み、これはその後、これらの条件下で一晩貯蔵された。
Claims (1)
- 宿主細胞中で発現させた抗体又はその抗原結合フラグメントの精製の間にジスルフィド結合の還元を防止する方法であって、
- 活性炭素濾過ステップと、それに続く
- プロテインAクロマトグラフィーと
を含む方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2021189889A JP2022036993A (ja) | 2016-04-01 | 2021-11-24 | タンパク質精製方法 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB201605562 | 2016-04-01 | ||
GB1605562.6 | 2016-04-01 | ||
PCT/EP2017/057685 WO2017167960A1 (en) | 2016-04-01 | 2017-03-31 | Method for protein purification |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2021189889A Division JP2022036993A (ja) | 2016-04-01 | 2021-11-24 | タンパク質精製方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2019512255A JP2019512255A (ja) | 2019-05-16 |
JP7012023B2 true JP7012023B2 (ja) | 2022-01-27 |
Family
ID=58461345
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2018551087A Active JP7012023B2 (ja) | 2016-04-01 | 2017-03-31 | タンパク質精製方法 |
JP2021189889A Abandoned JP2022036993A (ja) | 2016-04-01 | 2021-11-24 | タンパク質精製方法 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2021189889A Abandoned JP2022036993A (ja) | 2016-04-01 | 2021-11-24 | タンパク質精製方法 |
Country Status (18)
Country | Link |
---|---|
US (1) | US11014962B2 (ja) |
EP (1) | EP3436173A1 (ja) |
JP (2) | JP7012023B2 (ja) |
KR (1) | KR102413808B1 (ja) |
CN (1) | CN108883345B (ja) |
AU (1) | AU2017242900B2 (ja) |
BR (1) | BR112018068803A2 (ja) |
CA (1) | CA3016847C (ja) |
CL (1) | CL2018002689A1 (ja) |
CO (1) | CO2018010286A2 (ja) |
EA (1) | EA201892231A1 (ja) |
HK (1) | HK1257713A1 (ja) |
IL (1) | IL261560B (ja) |
MX (1) | MX2018011435A (ja) |
MY (1) | MY197993A (ja) |
RU (1) | RU2737539C2 (ja) |
SG (1) | SG11201807676UA (ja) |
WO (1) | WO2017167960A1 (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023136820A1 (en) * | 2022-01-13 | 2023-07-20 | Bayer Healthcare Llc | Improved antibody manufacture |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014024514A1 (ja) | 2012-08-07 | 2014-02-13 | 協和発酵キリン株式会社 | 蛋白質の精製方法 |
JP2015071629A (ja) | 2011-08-19 | 2015-04-16 | イー・エム・デイー・ミリポア・コーポレイシヨン | タンパク質精製中に試料中の1または複数の不純物のレベルを低下させる方法 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5659795A (en) * | 1979-10-22 | 1981-05-23 | Kanegafuchi Chem Ind Co Ltd | Purification of nicotinic acid amide adenine dinucleotide |
EP2350127B1 (en) * | 2008-10-20 | 2015-01-28 | AbbVie Inc. | Isolation and purification of antibodies using protein a affinity chromatography |
CN104105703A (zh) * | 2012-03-26 | 2014-10-15 | Emd密理博公司 | 带电的氟碳化合物组合物在纯化生物分子的方法中的用途 |
EP2682168A1 (en) * | 2012-07-02 | 2014-01-08 | Millipore Corporation | Purification of biological molecules |
ES2891752T3 (es) * | 2013-03-21 | 2022-01-31 | Evonik Operations Gmbh | Purificación de proteínas de triple hélice |
EP3019521A1 (en) | 2013-07-12 | 2016-05-18 | EMD Millipore Corporation | A method of determining virus removal from a sample containing a target protein using activated carbon |
US10519194B2 (en) * | 2013-07-12 | 2019-12-31 | Merck Patent Gmbh | Removal of fragments from a sample containing a target protein using activated carbon |
CN104546715B (zh) | 2014-12-22 | 2018-01-16 | 蓝佳堂生物医药(福建)有限公司 | 一种用于上呼吸道感染的复合抗体口腔喷剂及其制备方法 |
-
2017
- 2017-03-31 US US16/089,443 patent/US11014962B2/en active Active
- 2017-03-31 KR KR1020187031874A patent/KR102413808B1/ko active IP Right Grant
- 2017-03-31 AU AU2017242900A patent/AU2017242900B2/en active Active
- 2017-03-31 CN CN201780020300.8A patent/CN108883345B/zh active Active
- 2017-03-31 MY MYPI2018703312A patent/MY197993A/en unknown
- 2017-03-31 SG SG11201807676UA patent/SG11201807676UA/en unknown
- 2017-03-31 EP EP17714759.2A patent/EP3436173A1/en active Pending
- 2017-03-31 WO PCT/EP2017/057685 patent/WO2017167960A1/en active Application Filing
- 2017-03-31 CA CA3016847A patent/CA3016847C/en active Active
- 2017-03-31 MX MX2018011435A patent/MX2018011435A/es unknown
- 2017-03-31 RU RU2018138445A patent/RU2737539C2/ru active
- 2017-03-31 EA EA201892231A patent/EA201892231A1/ru unknown
- 2017-03-31 JP JP2018551087A patent/JP7012023B2/ja active Active
- 2017-03-31 BR BR112018068803A patent/BR112018068803A2/pt unknown
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2018
- 2018-09-03 IL IL261560A patent/IL261560B/en active IP Right Grant
- 2018-09-21 CL CL2018002689A patent/CL2018002689A1/es unknown
- 2018-09-26 CO CONC2018/0010286A patent/CO2018010286A2/es unknown
-
2019
- 2019-01-03 HK HK19100083.7A patent/HK1257713A1/zh unknown
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2021
- 2021-11-24 JP JP2021189889A patent/JP2022036993A/ja not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2015071629A (ja) | 2011-08-19 | 2015-04-16 | イー・エム・デイー・ミリポア・コーポレイシヨン | タンパク質精製中に試料中の1または複数の不純物のレベルを低下させる方法 |
WO2014024514A1 (ja) | 2012-08-07 | 2014-02-13 | 協和発酵キリン株式会社 | 蛋白質の精製方法 |
Also Published As
Publication number | Publication date |
---|---|
JP2019512255A (ja) | 2019-05-16 |
AU2017242900B2 (en) | 2022-07-28 |
KR102413808B1 (ko) | 2022-06-29 |
IL261560B (en) | 2021-06-30 |
HK1257713A1 (zh) | 2019-10-25 |
MY197993A (en) | 2023-07-25 |
SG11201807676UA (en) | 2018-10-30 |
CA3016847C (en) | 2023-12-19 |
CL2018002689A1 (es) | 2018-11-23 |
BR112018068803A2 (pt) | 2019-01-22 |
IL261560A (en) | 2018-10-31 |
CO2018010286A2 (es) | 2018-10-31 |
EP3436173A1 (en) | 2019-02-06 |
US11014962B2 (en) | 2021-05-25 |
EA201892231A1 (ru) | 2019-03-29 |
US20190153028A1 (en) | 2019-05-23 |
AU2017242900A1 (en) | 2018-10-04 |
CA3016847A1 (en) | 2017-10-05 |
CN108883345B (zh) | 2022-09-13 |
RU2737539C2 (ru) | 2020-12-01 |
JP2022036993A (ja) | 2022-03-08 |
WO2017167960A1 (en) | 2017-10-05 |
RU2018138445A3 (ja) | 2020-07-07 |
KR20180131599A (ko) | 2018-12-10 |
MX2018011435A (es) | 2019-01-10 |
RU2018138445A (ru) | 2020-05-12 |
CN108883345A (zh) | 2018-11-23 |
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