HRP20201118T1 - Izolacija i pročišćavanje prot-il-13 protutijela uporabom protein a afinitetne kromatografije - Google Patents
Izolacija i pročišćavanje prot-il-13 protutijela uporabom protein a afinitetne kromatografije Download PDFInfo
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- HRP20201118T1 HRP20201118T1 HRP20201118TT HRP20201118T HRP20201118T1 HR P20201118 T1 HRP20201118 T1 HR P20201118T1 HR P20201118T T HRP20201118T T HR P20201118TT HR P20201118 T HRP20201118 T HR P20201118T HR P20201118 T1 HRP20201118 T1 HR P20201118T1
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- sample
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- reduced
- mixture
- antibody
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- 238000001042 affinity chromatography Methods 0.000 title claims 3
- 102000004169 proteins and genes Human genes 0.000 title claims 3
- 108090000623 proteins and genes Proteins 0.000 title claims 3
- 238000002955 isolation Methods 0.000 title 1
- 238000000746 purification Methods 0.000 title 1
- 238000004191 hydrophobic interaction chromatography Methods 0.000 claims 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 5
- 239000000872 buffer Substances 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 230000005526 G1 to G0 transition Effects 0.000 claims 2
- 239000007983 Tris buffer Substances 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 239000012539 chromatography resin Substances 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- 125000001165 hydrophobic group Chemical group 0.000 claims 2
- 238000005342 ion exchange Methods 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims 2
- 230000020477 pH reduction Effects 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 2
- 238000005406 washing Methods 0.000 claims 2
- 125000000022 2-aminoethyl group Chemical group [H]C([*])([H])C([H])([H])N([H])[H] 0.000 claims 1
- 229920000936 Agarose Polymers 0.000 claims 1
- 239000005635 Caprylic acid (CAS 124-07-2) Substances 0.000 claims 1
- 125000000217 alkyl group Chemical group 0.000 claims 1
- 239000003957 anion exchange resin Substances 0.000 claims 1
- 150000001450 anions Chemical group 0.000 claims 1
- 125000003118 aryl group Chemical group 0.000 claims 1
- 238000011118 depth filtration Methods 0.000 claims 1
- 229960002446 octanoic acid Drugs 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 230000003612 virological effect Effects 0.000 claims 1
Classifications
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- 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
- A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
- A61K39/39525—Purification
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- 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
-
- 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]
-
- 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
-
- 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
-
- 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
-
- 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
-
- 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
- C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode 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
- C07K1/18—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
- C07K1/36—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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- 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]
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Rheumatology (AREA)
- Pulmonology (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports 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)
Claims (5)
1. Postupak proizvodnje preparata protu-IL-13 protutijela s reduciranim proteinom stanice domaćina (reduciran HCP) iz mješavine uzorka koji sadrži protu-IL-13 protutijelo i najmanje jedan HCP, pri čemu navedeni postupak sadrži:
(a) filtriranje navedene mješavine uzorka s filtrom za dubinsku filtraciju i sakupljanje dubinski filtrirane mješavine uzorka;
(b) dodirivanje dubinski filtrirane mješavine uzorka s Protein A afinitetnom kromatografskom smolom, ispiranje navedene afinitetne kromatografske smole puferom koji sadrži 25 mM Tris, 100 mM NaCl, pH 7.2, zatim ispiranje puferom koji sadrži 20 mM natrij citrat/limunsku kiselinu, 0.5 M NaCl, pH 6, i zatim puferom koji sadrži 25 mM Tris, 100 mM NaCl, pH 7.2 i sakupljanje afinitetnog kromatografskog uzorka;
(c) podvrgavanje navedenog afinitetnog kromatografskog uzorka redukciji u pH na taj način formirajući uzorak s reduciranim pH, pri čemu navedeni uzorak s reduciranim pH ima pH od oko 3 do oko 4;
(d) podešavanje pH navedenog uzorka s reduciranim pH do pH od oko 4.5 do oko 8.5 i dodirivanje navedenog uzorka s podešenim pH s anionskom izmjenjivačkom smolom koja sadrži kvaternarni aminoetil (QAE) anionski supstituent i sakupljanje ionskog izmjenjivačkog uzorka; i
(e) dodirivanje navedenog ionskog izmjenjivačkog uzorka s materijalom za kromatografiju s hidrofobnom interakcijom (HIC) i sakupljanje HIC uzorka, pri čemu navedeni HIC uzorak sadrži navedeni preparat protutijela s reduciranim HCP, pri čemu „oko“ označava do 20% veće od ili manje od referentne vrijednosti, i pri čemu navedeno protu-IL-13 protutijelo je humanizirano IgA1, IgA2, IgG1, IgG2, IgG4, ili IgM protutijelo koje sadrži varijabilnu regiju teškog lanca od
EVTLRESGPGLVKPTQTLTLTCTLYGFSLSTSDMGVDWIRQPPGKGLEWLAHIWWDDVKRYNPALKSRLTISKDTSKNQVVLKLTSVDPVDTATYYCARTVSSGYIYYAMDYWGQGTLVTVSS i varijabilnu regiju lakog lanca od
[image]
2. Postupak sukladno patentnom zahtjevu 1, naznačen time što navedena redukcija u pH u koraku (c) je postignuta miješanjem odgovarajuće kiseline s navedenom mješavinom uzorka, izborno pri čemu navedena odgovarajuća kiselina je odabrana iz skupine sastavljene od limunske kiseline, octene kiseline i kaprilne kiseline.
3. Postupak sukladno patentnom zahtjevu 1, naznačen time što navedeni HIC materijal je:
(i) HIC kolona čija stacionarna faza sadrži hidrofobne skupine, ili
(ii) HIC kolona čija stacionarna faza sadrži hidrofobne skupine odabrane iz skupine sastavljene od alkil-skupine, aril-skupine i njihove kombinacije; ili
(iii) agarozna smola supstituirana s fenil skupinom.
4. Postupak sukladno patentnom zahtjevu 1 koji dodatno sadrži korak filtriranja, pri čemu navedeni uzorak HIC je podvrgnut filtriranju da bi se uklonile virusne čestice i da bi se olakšala razmjena pufera.
5. Postupak sukladno patentnom zahtjevu 1 ili 2, naznačen time što navedeni uzorak s reduciranim pH u koraku (c) ima pH od oko 3.5.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US25341109P | 2009-10-20 | 2009-10-20 | |
| EP15189425.0A EP3037104B1 (en) | 2009-10-20 | 2010-10-20 | Isolation and purification of anti-il-13 antibodies using protein a affinity chromatography |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201118T1 true HRP20201118T1 (hr) | 2020-10-30 |
Family
ID=43900936
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201118TT HRP20201118T1 (hr) | 2009-10-20 | 2020-07-15 | Izolacija i pročišćavanje prot-il-13 protutijela uporabom protein a afinitetne kromatografije |
Country Status (27)
| Country | Link |
|---|---|
| US (5) | US8491904B2 (hr) |
| EP (2) | EP2491055A2 (hr) |
| JP (1) | JP5914342B2 (hr) |
| KR (2) | KR20170136649A (hr) |
| CN (2) | CN102711828B (hr) |
| AU (1) | AU2010310748C1 (hr) |
| BR (1) | BR112012009289B8 (hr) |
| CA (1) | CA2775595A1 (hr) |
| CY (1) | CY1123952T1 (hr) |
| DK (1) | DK3037104T3 (hr) |
| ES (1) | ES2813398T3 (hr) |
| HR (1) | HRP20201118T1 (hr) |
| HU (1) | HUE053489T2 (hr) |
| IL (1) | IL218897A (hr) |
| IN (1) | IN2012DN02778A (hr) |
| LT (1) | LT3037104T (hr) |
| MX (2) | MX2012004711A (hr) |
| NZ (2) | NZ599100A (hr) |
| PL (1) | PL3037104T3 (hr) |
| PT (1) | PT3037104T (hr) |
| RS (1) | RS60577B1 (hr) |
| RU (1) | RU2603055C2 (hr) |
| SG (1) | SG10201406713XA (hr) |
| SI (1) | SI3037104T1 (hr) |
| TW (1) | TWI515202B (hr) |
| WO (1) | WO2011050071A2 (hr) |
| ZA (1) | ZA201202720B (hr) |
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| CL2008003561A1 (es) * | 2007-11-30 | 2010-02-05 | Glaxo Group Ltd | Construccion de union a il - 13 que comprende a lo menos un dominio simple (dab) de anticuerpo injertado en un anticuerpo monoclonal ( mabdab); polinucleotido y celula huesped; procedimiento para preparar la construccion; composicion farmaceutica que la comprende y uso para tratar cancer o enfermedades inflamatorias. |
| JP5808249B2 (ja) * | 2008-10-20 | 2015-11-10 | アッヴィ・インコーポレイテッド | プロテインａアフィニティークロマトグラフィーを用いる抗体の単離および精製 |
| CN104974251A (zh) | 2008-10-20 | 2015-10-14 | Abbvie公司 | 在抗体纯化过程中的病毒灭活 |
| AU2010310748C1 (en) | 2009-10-20 | 2015-11-26 | Abbvie Inc. | Isolation and purification of anti-IL-13 antibodies using Protein A affinity chromatography |
| WO2012015908A2 (en) | 2010-07-30 | 2012-02-02 | Millipore Corporation | Chromatography media and method |
| EP3235508B1 (en) | 2011-03-16 | 2020-12-30 | Sanofi | Compositions comprising a dual v region antibody-like protein |
| WO2013130604A1 (en) * | 2012-02-27 | 2013-09-06 | Biogen Idec Ma Inc. | High-throughput method for sialic acid quantitation |
| PL2970378T3 (pl) * | 2013-03-15 | 2021-12-06 | Biogen Ma Inc. | Chromatografia oddziaływań hydrofobowych białek w warunkach bez soli |
| CA2910065C (en) * | 2013-05-15 | 2023-09-19 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| AR096713A1 (es) | 2013-06-25 | 2016-01-27 | Cadila Healthcare Ltd | Proceso de purificación para anticuerpos monoclonales |
| KR101847004B1 (ko) | 2013-07-12 | 2018-04-10 | 메르크 파텐트 게엠베하 | 표적 단백질을 함유하는 샘플로부터 단편들의 활성탄을 이용한 제거 |
| KR102332302B1 (ko) | 2013-09-13 | 2021-12-01 | 제넨테크, 인크. | 세포주에서 숙주 세포 단백질 및 재조합 폴리펩티드 생성물을 검출 및 정량화하기 위한 조성물 및 방법 |
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