ME02101B - Pročišćavanje antitijela hromatografijom izmjene katjona - Google Patents
Pročišćavanje antitijela hromatografijom izmjene katjonaInfo
- Publication number
- ME02101B ME02101B MEP-2015-34A MEP3415A ME02101B ME 02101 B ME02101 B ME 02101B ME P3415 A MEP3415 A ME P3415A ME 02101 B ME02101 B ME 02101B
- Authority
- ME
- Montenegro
- Prior art keywords
- cation exchange
- antibody
- exchange material
- washing
- buffer
- Prior art date
Links
Classifications
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/08—Vasodilators for multiple indications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
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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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Analytical Chemistry (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Hematology (AREA)
- Ophthalmology & Optometry (AREA)
- Pain & Pain Management (AREA)
- Oncology (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Vascular Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
Claims (15)
1. Postupak za pročišćavanje antitela iz sastava koji sadrži antitelo i najmanje jedan zagađivač, gde postupak obuhvata sledeće uzastopne korake:a)nanošenje sastava na materijal izmene katjona, gde je sastav na početku na pH od 4,0 do 6,0;b)ispiranje materijala izmene katjona prvim puferom za ispiranje, gde je pH prvog pufera za ispiranje od 6,8 do 9,0;c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; id)eluciju antitela iz materijala izmene katjona puferom za eluciju na provodnosti koja je najmanje 2 mS/cm veća od one kod drugog pufera za ispiranje.
2. Postupak prema patentnom zahtevu 1 gde su pH drugog pufera za ispiranje i pH pufera za eluciju približno isti.
3. Postupak prema patentnom zahtevu 1 gde se antitelo vezuje na humani CD20.
4. Postupak prema patentnom zahtevu 1 gde se antitelo vezuje na humani vaskularni endotelni faktor rasta (VEGF).
5. Postupak prema patentnom zahtevu 1 gde je pH sastava kod (a) od 4,0 do 6,0, pH prvog pufera za ispiranje je od 6,8 do 8,0, pH drugog pufera za ispiranje od 5,0 do 6.0, a pH pufera za eluciju je od 5,0 do 6,0.
6. Postupak prema patentnom zahtevu 1 gde je provodnost pufera za eluciju od 10 mS/cm do 100 mS/cm.
7. Postupak prema patentnom zahtevu 1 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
8. Postupak prema patentnom zahtevu 1, gde materijal izmene katjona sadrži unakrsno spojene poli(stiren-divinilbenzen) protočne čestice obložene polihidroksiliranim polimerom koji je funkcionalizovan sulfopropil grupama.
9. Postupak prema patentnom zahtevu 1 gde je zagađivač odabran iz grupe koja se sastoji od proteina jajnih ćelija kineskog hrčka (CHOP), izlučenog proteina A, DNK, nagomilanih antitela, komponente medijuma ćelijske kulture, garamicina i virusnih zagađenja.
10. Postupak za pročišćavanje antitela koje vezuje humani CD20 iz sastava koji sadrži antitelo i jedan ili više zagađivač odabranih iz skupine koja se sastoji od proteina jajnih ćelija kineskog hrčka (CHOP), ispranog proteina A, DNK, nagomilanoih CD20 antitela, gde postupak obuhvata sledeće uzastopne korake: a)nanošenje sastava na materijal izmene katjona, gde je sastav na pH od 4,0 do 6,0; b)ispiranje materijala izmene katjona prvom puferom za ispiranje na 6,8 do 9,0; c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; i d)eluciju antitela iz materijala izmene katjona puferom za eluciju sa ph od 5,0 do 6,0 i provodnosti od 10 mS/cm do 100 mS/cm.
11. Postupak prema patentnom zahtevu 10 gde je antitelo rituksimab.
12. Postupak prema patentnom zahtevu 10 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
13. Postupak za pročišćavanje antitela koje vezuje humani vaskularni endotelni faktor rasta (VEGF) iz sastava koji sadrži antitelo i jedan ili više zagađivača odabranih iz grupe koja se sastoji od komponente medijuma ćelijske kulture, garamicina, proteina jajnih ćelija kineskog hrčka (CHOPS) DNK, virusnih zagađivača i nagomilanih VEGF antitela, gde postupak obuhvata sledeće uzastopne korake: a)nanošenje sastava na materijal izmene katjona, gde je sastav na pH od 4,0 do 6,0; b)ispiranje materijala izmene katjona prvom puferom za ispiranje na 6,8 do 8,0; c)ispiranje materijala izmene katjona drugim puferom za ispiranje pri pH od 5,0 do 6,0; i d)eluciju antitela iz materijala izmene katjona puferom za eluciju sa ph od 5,0 do 6,0 i provodnosti od 10 mS/cm do 100 mS/cm.
14. Postupak prema patentnom zahtevu 13 gde je antitelo bevacizumab.
15. Postupak prema patentnom zahtevu 13 gde se pufer za eluciju sastoji od 100 do 300 mM NaCl.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US98382507P | 2007-10-30 | 2007-10-30 | |
| EP08844379.1A EP2215117B2 (en) | 2007-10-30 | 2008-10-29 | Antibody purification by cation exchange chromatography |
| PCT/US2008/081516 WO2009058812A1 (en) | 2007-10-30 | 2008-10-29 | Antibody purification by cation exchange chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02101B true ME02101B (me) | 2015-10-20 |
Family
ID=40262967
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2015-34A ME02101B (me) | 2007-10-30 | 2008-10-29 | Pročišćavanje antitijela hromatografijom izmjene katjona |
Country Status (32)
| Country | Link |
|---|---|
| US (3) | US20090148435A1 (me) |
| EP (4) | EP2565206B1 (me) |
| JP (5) | JP5237382B2 (me) |
| KR (3) | KR20140015166A (me) |
| CN (3) | CN103554215B (me) |
| AR (2) | AR069097A1 (me) |
| AU (1) | AU2008318865B2 (me) |
| BR (1) | BRPI0817182A2 (me) |
| CA (1) | CA2703279C (me) |
| CL (1) | CL2008003218A1 (me) |
| CO (1) | CO6280422A2 (me) |
| CY (1) | CY1116129T1 (me) |
| DK (3) | DK2840090T3 (me) |
| ES (3) | ES2533266T5 (me) |
| HK (1) | HK1221234A1 (me) |
| HR (2) | HRP20150282T4 (me) |
| HU (3) | HUE024877T2 (me) |
| IL (4) | IL205310A0 (me) |
| ME (1) | ME02101B (me) |
| MX (1) | MX2010004740A (me) |
| NZ (1) | NZ584839A (me) |
| PE (1) | PE20091434A1 (me) |
| PH (1) | PH12013501128A1 (me) |
| PL (3) | PL2565206T3 (me) |
| PT (1) | PT2215117E (me) |
| RS (1) | RS53850B2 (me) |
| RU (1) | RU2498991C2 (me) |
| SG (2) | SG10201401690XA (me) |
| SI (3) | SI2215117T2 (me) |
| TW (2) | TWI554517B (me) |
| WO (1) | WO2009058812A1 (me) |
| ZA (2) | ZA201002850B (me) |
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