KR20080017322A - 항체의 정제 방법 - Google Patents
항체의 정제 방법 Download PDFInfo
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- KR20080017322A KR20080017322A KR1020077027285A KR20077027285A KR20080017322A KR 20080017322 A KR20080017322 A KR 20080017322A KR 1020077027285 A KR1020077027285 A KR 1020077027285A KR 20077027285 A KR20077027285 A KR 20077027285A KR 20080017322 A KR20080017322 A KR 20080017322A
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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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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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
- B01D15/26—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
- B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
- B01D15/424—Elution mode
- B01D15/426—Specific type of solvent
-
- 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
- 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
- C07K16/28—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
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- 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
- G01N30/96—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 using ion-exchange
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
Abstract
Description
Claims (10)
- a) 면역글로불린, 완충 물질, 및 선택적으로 염을 포함하는 용액을 제공하고;b) 상기 용액 및 약이온 교환 물질을 면역글로불린이 약이온 교환 물질에 결합하는 조건하에서 접촉시키고;c) 완충 물질 및 염을 포함하는 용액을 이용하여 단일 단계로 약이온 교환 물질로부터 면역글로불린을 회수하는 단계를 포함하는, 면역글로불린의 정제 방법.
- 제 1 항에 있어서,상기 약이온 교환 물질이 약한 양이온 교환 물질인 것을 특징으로 하는 방법.
- 제 1 항 또는 제 2 항에 있어서,상기 완충 물질이 시트르산 또는 그의 염, 또는 인산 또는 그의 염인 것을 특징으로 하는 방법.
- 제 1 항 내지 제 3 항 중 어느 한 항에 있어서,크로마토그래피 또는 배치 방법인 것을 특징으로 하는 방법.
- 제 1 항 내지 제 4 항 중 어느 한 항에 있어서,단계 c)에서의 염이 염화나트륨, 황산나트륨, 염화칼륨, 황산칼륨, 시트르산 염, 인산 염 및 이들 성분들의 혼합물로 이루어진 군에서 선택되는 것을 특징으로 하는 방법.
- 제 1 항 내지 제 5 항 중 어느 한 항에 있어서,상기 면역글로불린이 면역글로불린 부류 G 또는 E의 구성원인 것을 특징으로 하는 방법.
- 제 1 항 내지 제 6 항 중 어느 한 항에 있어서,회수 단계 c)에서의 용액이 pH 3.0 내지 7.0의 pH 값을 갖는 것을 특징으로 하는 방법.
- 하기의 두 단계를 포함하는, 단일 단계 정제 공정에서 이온 교환 크로마토그래피 물질로부터 폴리펩타이드를 용출하기 위한 염의 농도를 측정하는 방법:(a) 다음의 부단계를 포함하는 단계 1:a1) 폴리펩타이드, 완충 물질 및 선택적으로 염을 포함하는 용액을 제공하고;a2) 폴리펩타이드를 함유하는 용액 제 1 분취량과 이온 교환 물질을 폴리펩 타이드가 이온 교환 물질에 결합하는 조건하에서 접촉시키고;a3) 완충 물질 및 염을 포함하는 용액을 이용하여 이온 교환 물질로부터 폴리펩타이드를 회수하여 염 농도를 선형으로 증가시키고;a4) 폴리펩타이드의 제 1 분획이 이온 교환 컬럼으로부터 용출되기 시작하는 염의 출발 농도를 측정한다;(b) 다음의 부단계를 포함하는 단계 2:b1) 폴리펩타이드를 함유하는 용액 제 2 분취량과 이온 교환 물질을 폴리펩타이드가 이온 교환 물질에 결합하는 조건하에서 접촉시키고;b2) 3 단계 용출 방법을 이용하여 이온 교환 물질로부터 폴리펩타이드를 회수하고, 이때, i) 제 1 용출 단계의 염 농도는, 단계 a4)에서 측정한 바와 같은 염의 출발 농도와 염의 분자식에 나타낸 수소 이외의 다른 1가 양이온의 총수의 곱과, 완충 염의 농도와 완충 염의 분자식에 나타낸 수소 이외의 다른 1가 양이온의 총수의 곱의 합으로 계산하고; ii) 제 2 용출 단계의 염 농도는 제 1 용출 단계의 염 농도와 1.25 내지 1.35의 계수의 곱이고; iii) 제 3 용출 단계의 염 농도는 제 1 용출 단계의 염 농도와 1.50 내지 1.70의 계수의 곱이며; 단계 ii) 및 iii)의 계수는, 10 내지 40 mM의 출발 농도에서 계수는 각각 1.35 및 1.70이고, 40 내지 70 mM의 출발 농도에서 계수는 각각 1.30 및 1.60이고, 70 mM 이상의 출발 농도에서 계수는 각각 1.25 및 1.50인 것으로 결정되며;b3) 단계 b2)의 3 단계 용출 방법의 어느 부단계에서 폴리펩타이드가 이온 교환 컬럼으로부터 용출되는지를 측정하여, 단일 단계 정제 공정에서 이온 교환 크 로마토그래피 물질로부터 폴리펩타이드를 용출하기 위한 염 농도를 측정한다.
- 제 8 항에 있어서,상기 이온 교환 크로마토그래피 물질이 약이온 교환 크로마토그래피 물질인 것을 특징으로 하는 방법.
- 제 8 항 또는 제 9 항에 있어서,상기 폴리펩타이드가 면역글로불린인 것을 특징으로 하는 방법.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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EP05011302 | 2005-05-25 | ||
EP05011302.6 | 2005-05-25 |
Publications (2)
Publication Number | Publication Date |
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KR20080017322A true KR20080017322A (ko) | 2008-02-26 |
KR100967778B1 KR100967778B1 (ko) | 2010-07-05 |
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KR1020077027285A KR100967778B1 (ko) | 2005-05-25 | 2006-05-23 | 항체의 정제 방법 |
Country Status (18)
Country | Link |
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US (3) | US20090098660A1 (ko) |
EP (2) | EP2261252B2 (ko) |
JP (1) | JP4852602B2 (ko) |
KR (1) | KR100967778B1 (ko) |
CN (1) | CN101180317B (ko) |
AT (1) | ATE525087T1 (ko) |
AU (1) | AU2006251307B2 (ko) |
BR (1) | BRPI0610201B8 (ko) |
CA (1) | CA2607375C (ko) |
DK (1) | DK1888636T4 (ko) |
ES (2) | ES2389641T5 (ko) |
FI (1) | FI1888636T4 (ko) |
IL (2) | IL186338A (ko) |
MX (1) | MX2007014269A (ko) |
NO (1) | NO345362B1 (ko) |
PL (1) | PL1888636T5 (ko) |
TW (2) | TWI391399B (ko) |
WO (1) | WO2006125599A2 (ko) |
Cited By (1)
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WO2015064971A1 (ko) * | 2013-10-30 | 2015-05-07 | (주)셀트리온 | 양이온 교환 크로마토그래피를 이용한 항체의 아형 분리 방법 |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2015064971A1 (ko) * | 2013-10-30 | 2015-05-07 | (주)셀트리온 | 양이온 교환 크로마토그래피를 이용한 항체의 아형 분리 방법 |
US10351592B2 (en) | 2013-10-30 | 2019-07-16 | Celltrion, Inc. | Method for separating antibody isoforms using cation exchange chromatography |
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