KR960007612A - 재조합 사람 혈청 알부민의 정제방법 - Google Patents

재조합 사람 혈청 알부민의 정제방법 Download PDF

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KR960007612A
KR960007612A KR1019950027882A KR19950027882A KR960007612A KR 960007612 A KR960007612 A KR 960007612A KR 1019950027882 A KR1019950027882 A KR 1019950027882A KR 19950027882 A KR19950027882 A KR 19950027882A KR 960007612 A KR960007612 A KR 960007612A
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human serum
serum albumin
recombinant human
treatment
albumin
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KR100392021B1 (ko
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무네히로 노사
아키노리 수미
다카오 오무라
가즈미사 요코야마
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가와노 다케히코
가부시키가이샤 미도리쥬지
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76Albumins
    • C07K14/765Serum albumin, e.g. HSA
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P1/00Preparation of compounds or compositions, not provided for in groups C12P3/00 - C12P39/00, by using microorganisms or enzymes

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Abstract

본 발명은 제조합 사람 혈청 알부민(rHSA) alc rHSA-생성숙주 세포를 함유하는 배양 배지를 가열하고, 흡착제 입자가 이들과 접촉을 이루도록 현탁되어 있는 유동충내로 가열 용액을 상부를 향해 공급한 후, rHSA를 함유하는 흡착 분획을 회수함으로써 rHSA을 정제하는 방법, 및 25% 알부민 용액으로 제형시 이하의 A350/A280비가 0.015 미만인 rHSA를 함유하는 조성물을 제공한다.

Description

재조합 사람 혈청 알부민의 정제방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 rHSA 배양 배지에 미치는 가열처리의 안정화 효과를 보여주는 그래프도이다.
제3도는 스트림라인(Steamline)SP를 사용하게 (효모 세포를 함유하는)배양 배지로부터 rHSA 정제의 최적 흐름도를 나타내는 작업 공정도이다.

Claims (9)

  1. 재조합 사람 혈청 알부민 및 이를 생성하는 숙주 세포를 함유하는 배양 배지를 가열하고, 가열 용액을 알부민을 선택적으로 흡착하기 위한 조건하에서 유동층에 현탁된 흡착제 입자와 접촉시킨 다음, 흡착 분획을 회수함을 특징으로 하는, 재조합 사람 혈청 알부민 정제 방법.
  2. 제1항에 있어서, 재조합 사람 혈청 알부민 및 이를 생성하는 숙주 세포를 함유하는 배양 배지를 가열하고, 알부민을 선택적으로 흡착하기 위한 조건하에서 가열하고, 알부민을 선택적으로 흡착하기 위한 조건하에서 가열용액과 흡착제 입자가 접촉을 이루도록 흡착제 입자가 현탁되어 있는 유동층내로 상부를 향해 가열 용액을 공급한 다음, 유동 방향을 용출시키고 회수함을 특징으로 하는, 재조합 사람 혈청 알부민 정제 방법.
  3. 제1항 또는 제2항에 있어서, 가열이 50 내지 100℃에서 1분 내지 10시간 동안 수행되는 재조합 사람 혈청 알부민 정제방법.
  4. 제3항에 있어서, 가열된 용액이 pH 약 3 내지 5에서 흡착제 입자와 접촉되는 재조합 사람 혈청 알부민 정제 방법.
  5. 제4항에 있어서, 가열 용액이 0.1 내지 50mS의 전기 전도율의 대기중에서 흡착제 입자와 접촉되는 재조합 사람 혈청 알부민 정제방법.
  6. 제5항에 있어서, 흡착제 입자가 강한 양이온 교환 그룹을 갖는 재조합 사람 혈청 알부민 정제방법.
  7. 제1항 또는 제2항에 따른 정제 방법에 의해 회수된 사람 혈청 알부민을 함유하는 흡착 분획을 소수성 크로마토그래피, 음이온 교환제 처리, 킬레이트 수지 처리, 붕산/붕산염 처리 및 한외여과막 처리로 이루어진 그룹 중에서 선택된 하나 이상의 정제처리에 추가로 적용시키는 재조합 사람 혈청 알부민 정제방법.
  8. 제1항 또는 제2항에 따른 정제 방법에 의해 회수된 사람 혈청 알부민을 함유하는 흡착 분획을 환원제의 존재하에 가열시킨 다음, 소수성 크로마토그래피, 음이온 교환제 처리, 킬레이트 수지 처리, 붕산/붕산염 처리 및 한외여과막 처리로 이루어진 그룹 중에서 선택된 하나 이상의 정제처리를 하는 재조합 사람 혈청 알부민 정제방법.
  9. 25% 알부민 용액으로 제형시 A350/A280 비가 0.015 미만인 재조합 사람 혈청 알부민을 함유하는 사람 혈청 알부민-함유 조성물.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950027882A 1994-08-31 1995-08-31 재조합 사람혈청알부민의 정제방법 KR100392021B1 (ko)

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JP20770494 1994-08-31
JP94-207704 1994-08-31

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US (2) US5962649A (ko)
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DK (1) DK0699687T3 (ko)
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TW363065B (en) 1999-07-01
CA2157219C (en) 2010-10-05
EP0699687A2 (en) 1996-03-06
ES2211889T3 (es) 2004-07-16
EP0699687A3 (en) 1996-12-18
DK0699687T3 (da) 2004-04-26
DE69532492T2 (de) 2004-12-02
CN1364643A (zh) 2002-08-21
EP0699687B1 (en) 2004-01-28
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