HRP20210588T1 - Ionoizmjenjivačka kromatografija s poboljšanom selektivnošću za odvajanje polipeptidnih monomera, agregata i fragmenata modulacijom mobilne faze - Google Patents
Ionoizmjenjivačka kromatografija s poboljšanom selektivnošću za odvajanje polipeptidnih monomera, agregata i fragmenata modulacijom mobilne faze Download PDFInfo
- Publication number
- HRP20210588T1 HRP20210588T1 HRP20210588TT HRP20210588T HRP20210588T1 HR P20210588 T1 HRP20210588 T1 HR P20210588T1 HR P20210588T T HRP20210588T T HR P20210588TT HR P20210588 T HRP20210588 T HR P20210588T HR P20210588 T1 HRP20210588 T1 HR P20210588T1
- Authority
- HR
- Croatia
- Prior art keywords
- ethylene glycol
- poly
- glycine
- mass concentration
- antibody
- Prior art date
Links
- 238000004255 ion exchange chromatography Methods 0.000 title claims 3
- 239000012615 aggregate Substances 0.000 title 1
- 239000012634 fragment Substances 0.000 title 1
- 239000000178 monomer Substances 0.000 title 1
- 229920001184 polypeptide Polymers 0.000 title 1
- 102000004196 processed proteins & peptides Human genes 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 title 1
- 238000000926 separation method Methods 0.000 title 1
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 24
- -1 poly(ethylene glycol) Polymers 0.000 claims 16
- 239000000463 material Substances 0.000 claims 15
- 229920001223 polyethylene glycol Polymers 0.000 claims 13
- 239000004471 Glycine Substances 0.000 claims 12
- 238000000034 method Methods 0.000 claims 9
- 238000004519 manufacturing process Methods 0.000 claims 5
- 229920000232 polyglycine polymer Polymers 0.000 claims 4
- 238000005341 cation exchange Methods 0.000 claims 3
- 210000004027 cell Anatomy 0.000 claims 2
- 238000011091 antibody purification Methods 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 210000004962 mammalian cell Anatomy 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 150000007523 nucleic acids Chemical class 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
-
- 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
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- 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
- C07K16/244—Interleukins [IL]
-
- C—CHEMISTRY; METALLURGY
- 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
- C07K16/26—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
-
- C—CHEMISTRY; METALLURGY
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- C—CHEMISTRY; METALLURGY
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Endocrinology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (8)
1. Postupak za proizvodnju protutijela IgG klase u monomernom obliku, naznačen time, da obuhvaća sljedeće korake:
- primjena prve otopine koja po potrebi sadrži poli (etilen glikol) i glicin za kationsku izmjenu na kromatografskom materijalu, čime se materijal uravnotežuje,
- primjena otopine koja sadrži protutijelo IgG klase na uravnoteženi kromatografski materijal, čime se nanosi na kromatografski materijal,
- proizvodnja protutijela IgG klase u monomernom obliku primjenom otopine na kromatografskom materijalu koji sadrži poli (etilen glikol) i glicin, čime se desorbira/eluira protutijelo IgG klase u monomernom obliku iz kromatografskog materijala,
pri čemu poli (etilen glikol) ima masenu koncentraciju od 10% i glicin ima masenu koncentraciju od 1% do 8%.
2. Postupak za proizvodnju protutijela iz pripravka IgG klase s reduciranim sadržajem proteina u stanici domaćina, naznačen time, da obuhvaća sljedeće korake:
- primjena prve otopine koja po potrebi sadrži poli (etilen glikol) i glicin za kationsku izmjenu na kromatografskom materijalu, čime se materijal uravnotežuje,
- primjena otopine koja sadrži protutijelo IgG klase na uravnoteženi kromatografski materijal, čime se nanosi na kromatografski materijal,
- proizvodnja protutijela IgG klase u monomernom obliku primjenom otopine na kromatografskom materijalu koji sadrži poli (etilen glikol) i glicin, čime se desorbira/eluira
protutijelo IgG klase u monomernom obliku iz kromatografskog materijala,
pri čemu poli (etilen glikol) ima masenu koncentraciju od 10 % i glicin ima masenu koncentraciju od 1% do 8%.
3. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da poli (etilen glikol) ima masenu koncentraciju od 10 % i glicin ima masenu koncentraciju od 2 % do 8 %.
4. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da poli (etilen glikol) ima masenu koncentraciju od 10 % i glicin ima masenu koncentraciju od 4 % do 8 %.
5. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da poli (etilen glikol) ima masenu koncentraciju od 10 % i glicin ima masenu koncentraciju od 8 %.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da poli (etilen glikol) ima molekulsku masu od 3.500 Da +/- 20 %.
7. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da monomerna protutijela imaju molekulsku masu od 100 kDa do 200 kDa.
8. Postupak za proizvodnju četiri lanca pune dužine CrossMab protutijela u monomernom obliku, naznačen time, da obuhvaća sljedeće korake:
a) kultiviranje stanice sisavaca koja obuhvaća nukleinsku kiselinu koja kodira protutijelo i dobivanje protutijela iz stanice ili medija za uzgoj,
b) pročišćavanje protutijela kromatografskim postupkom kationske izmjene koji obuhvaća sljedeće korake:
- primjena otopine koja sadrži poli (etilen glikol) i glicin na kromatografskom materijalu na koji je protutijelo adsorbirano, pri čemu četiri lanca pune dužine protutijela u monomernom obliku ostaju adsorbirani na materijalu za ionoizmjenjivačku kromatografiju i
- dobivanje četiri lanca pune dužine CrossMab protutijela u monomernom obliku iz materijala za ionoizmjenjivačku kromatografiju primjenom otopine koja sadrži poli (etilen glikol) i glicin, pri čemu poli (etilen glikol) ima masenu koncentraciju od 10 % i glicin ima masenu koncentraciju od 1 % do 8 %, na taj način proizvodeći protutijelo.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11158523 | 2011-03-16 | ||
| EP17201391.4A EP3318571B1 (en) | 2011-03-16 | 2012-03-14 | Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210588T1 true HRP20210588T1 (hr) | 2021-05-28 |
Family
ID=45819216
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180028TT HRP20180028T4 (hr) | 2011-03-16 | 2018-01-08 | Kromatografija izmjene iona s poboljšanom selektivnošću za odvajanje polipeptidnih monomera, agregata i fragmenata modulacijom pokretne faze |
| HRP20210588TT HRP20210588T1 (hr) | 2011-03-16 | 2021-04-13 | Ionoizmjenjivačka kromatografija s poboljšanom selektivnošću za odvajanje polipeptidnih monomera, agregata i fragmenata modulacijom mobilne faze |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180028TT HRP20180028T4 (hr) | 2011-03-16 | 2018-01-08 | Kromatografija izmjene iona s poboljšanom selektivnošću za odvajanje polipeptidnih monomera, agregata i fragmenata modulacijom pokretne faze |
Country Status (9)
| Country | Link |
|---|---|
| US (3) | US9394337B2 (hr) |
| EP (2) | EP3318571B1 (hr) |
| JP (3) | JP5984854B2 (hr) |
| ES (2) | ES2656167T5 (hr) |
| HR (2) | HRP20180028T4 (hr) |
| PL (2) | PL3318571T3 (hr) |
| SG (1) | SG193378A1 (hr) |
| SI (2) | SI2686334T2 (hr) |
| WO (1) | WO2012123488A1 (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5984854B2 (ja) | 2011-03-16 | 2016-09-06 | エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | 移動相の調整によって、ポリペプチド単量体、凝集物およびフラグメントを分離するための選択性を向上させた、イオン交換クロマトグラフィー |
| WO2014018420A1 (en) * | 2012-07-21 | 2014-01-30 | K-Technologies, Inc. | Processes for the removal and recovery of minor elements in wet-process phosphoric acid |
| JP6285532B2 (ja) | 2013-03-14 | 2018-02-28 | イー・エム・デイー・ミリポア・コーポレイシヨン | タンパク質ａに基づくクロマトグラフィを使用するタンパク質純度を増加させる方法 |
| GB2516808A (en) * | 2013-05-31 | 2015-02-11 | Innova Biosciences Ltd | Antibody composition and buffer system therefor |
| MX2016001601A (es) * | 2013-08-19 | 2016-05-02 | Hoffmann La Roche | Separacion de anticuerpos biespecificos y subproductos de produccion de anticuerpos biespecificos utilizando cromatografia de hidroxiapatita. |
| WO2022133262A1 (en) * | 2020-12-20 | 2022-06-23 | Regeneron Pharmaceuticals, Inc. | Methods for identification of scrambled disulfides in biomolecules |
| CN113388026B (zh) * | 2021-08-03 | 2022-09-27 | 江西理工大学 | 一种螺旋藻藻蓝蛋白和藻油的同步提取方法 |
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| US5202238A (en) | 1987-10-27 | 1993-04-13 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5204244A (en) | 1987-10-27 | 1993-04-20 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5429746A (en) | 1994-02-22 | 1995-07-04 | Smith Kline Beecham Corporation | Antibody purification |
| JP2002517406A (ja) | 1998-06-01 | 2002-06-18 | ジェネンテック・インコーポレーテッド | イオン交換クロマトグラフィーの使用による、凝集体からのタンパク質モノマーの分離 |
| ES2527915T3 (es) * | 1998-06-09 | 2015-02-02 | Csl Behring Ag | Producto de inmunoglobulina G (IgG) líquido |
| ES2229784T3 (es) | 1998-06-09 | 2005-04-16 | Statens Serum Institut | Proceso de produccion de inmunoglobulinas para administracion intravenosa y otros productos de inmunoglobulina. |
| DE19836213A1 (de) * | 1998-08-11 | 2000-02-24 | Gerhard Harry Scholz | Verfahren zur Elution von Biomolekülen von Chromatographie-Materialien |
| AU2003257188A1 (en) | 2002-08-06 | 2004-02-23 | Akzo Nobel Patent Department | Increased dynamic binding capacity in ion exchange chromatography by addition of polyethylene glycol |
| CN1208346C (zh) | 2003-04-09 | 2005-06-29 | 中国科学院过程工程研究所 | 血红蛋白－人血清白蛋白偶联物制备血液代用品及其制备方法 |
| SE0400886D0 (sv) | 2004-04-02 | 2004-04-02 | Amersham Biosciences Ab | Process of purification |
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| WO2009015063A2 (en) * | 2007-07-23 | 2009-01-29 | Centocor | Methods and compositions for treating fibrosis related disorders using il-17 antagonists |
| CA2709354C (en) * | 2007-12-21 | 2014-06-17 | Amgen Inc. | Anti-amyloid antibodies and uses thereof |
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| WO2009149067A1 (en) † | 2008-06-03 | 2009-12-10 | Patrys Limited | Process for purification of antibodies |
| MY153893A (en) | 2008-09-29 | 2015-04-15 | Roche Glycart Ag | Antibodies against human il17 and uses thereof |
| US8268314B2 (en) | 2008-10-08 | 2012-09-18 | Hoffmann-La Roche Inc. | Bispecific anti-VEGF/anti-ANG-2 antibodies |
| CN105861454B (zh) | 2009-06-16 | 2020-03-03 | 建新公司 | 用于纯化重组aav载体的改进方法 |
| US8394922B2 (en) * | 2009-08-03 | 2013-03-12 | Medarex, Inc. | Antiproliferative compounds, conjugates thereof, methods therefor, and uses thereof |
| AR080793A1 (es) * | 2010-03-26 | 2012-05-09 | Roche Glycart Ag | Anticuerpos biespecificos |
| JP5984854B2 (ja) | 2011-03-16 | 2016-09-06 | エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | 移動相の調整によって、ポリペプチド単量体、凝集物およびフラグメントを分離するための選択性を向上させた、イオン交換クロマトグラフィー |
-
2012
- 2012-03-14 JP JP2013558420A patent/JP5984854B2/ja active Active
- 2012-03-14 EP EP17201391.4A patent/EP3318571B1/en active Active
- 2012-03-14 SI SI201231179T patent/SI2686334T2/sl unknown
- 2012-03-14 WO PCT/EP2012/054449 patent/WO2012123488A1/en active Application Filing
- 2012-03-14 EP EP12708546.2A patent/EP2686334B2/en active Active
- 2012-03-14 SG SG2013067947A patent/SG193378A1/en unknown
- 2012-03-14 SI SI201231907T patent/SI3318571T1/sl unknown
- 2012-03-14 PL PL17201391T patent/PL3318571T3/pl unknown
- 2012-03-14 ES ES12708546T patent/ES2656167T5/es active Active
- 2012-03-14 ES ES17201391T patent/ES2865449T3/es active Active
- 2012-03-14 PL PL12708546T patent/PL2686334T5/pl unknown
-
2013
- 2013-09-12 US US14/025,622 patent/US9394337B2/en active Active
-
2016
- 2016-06-16 US US15/184,883 patent/US10377793B2/en active Active
- 2016-08-02 JP JP2016151624A patent/JP6273326B2/ja active Active
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2018
- 2018-01-05 JP JP2018000397A patent/JP6523491B2/ja active Active
- 2018-01-08 HR HRP20180028TT patent/HRP20180028T4/hr unknown
-
2019
- 2019-06-24 US US16/450,827 patent/US20200148719A1/en not_active Abandoned
-
2021
- 2021-04-13 HR HRP20210588TT patent/HRP20210588T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HRP20180028T1 (hr) | 2018-02-09 |
| EP2686334B2 (en) | 2020-07-01 |
| PL3318571T3 (pl) | 2021-07-05 |
| EP3318571B1 (en) | 2021-02-17 |
| JP2017019805A (ja) | 2017-01-26 |
| HRP20180028T4 (hr) | 2020-10-02 |
| JP2018058900A (ja) | 2018-04-12 |
| ES2865449T3 (es) | 2021-10-15 |
| ES2656167T3 (es) | 2018-02-23 |
| SI3318571T1 (sl) | 2021-08-31 |
| JP5984854B2 (ja) | 2016-09-06 |
| JP6523491B2 (ja) | 2019-06-05 |
| PL2686334T3 (pl) | 2018-03-30 |
| ES2656167T5 (es) | 2021-03-26 |
| EP3318571A1 (en) | 2018-05-09 |
| US20140081000A1 (en) | 2014-03-20 |
| JP6273326B2 (ja) | 2018-01-31 |
| EP2686334A1 (en) | 2014-01-22 |
| US20200148719A1 (en) | 2020-05-14 |
| US20170107249A1 (en) | 2017-04-20 |
| US10377793B2 (en) | 2019-08-13 |
| JP2014511829A (ja) | 2014-05-19 |
| SI2686334T1 (en) | 2018-03-30 |
| US9394337B2 (en) | 2016-07-19 |
| WO2012123488A1 (en) | 2012-09-20 |
| EP2686334B1 (en) | 2017-11-15 |
| PL2686334T5 (pl) | 2020-10-19 |
| SG193378A1 (en) | 2013-10-30 |
| SI2686334T2 (sl) | 2020-10-30 |
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