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Biotechnology and bioprocess engineering v.15 no.3, 2010년, pp.488 - 496   SCIE
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Verification of the Final Anion Exchange Chromatography in the r-hGH Manufacturing Process

Min, Byeong-Jo    (College of Life Sciences and Biotechnology, Korea University   ); Kang, Seong-Woo    (Department of Chemical and Biological Engineering, Korea University   ); Song, Yoon-Seok    (Department of Chemical and Biological Engineering, Korea University   ); Lee, Jong-Ho    (Department of Chemical and Biological Engineering, Korea University   ); Lee, Seung-Heon    (Department of Chemical Engineering, Kwangwoon University   ); Park, Chul-Hwan    (Department of Chemical Engineering, Kwangwoon University   ); Kim, Seung-Wook    (Department of Chemical and Biological Engineering, Korea University   ); Kim, Chan-Wha    (College of Life Sciences and Biotechnology, Korea University  );
  • 초록

    In this study, final anion exchange chromatography in the recombinant human growth hormone (r-hGH) manufacturing process was validated using a validation protocol that was consistent with both policy and standard operation procedure (SOP). Two buffer solutions used in chromatography were first validated and were found to satisfy pre-established acceptance criteria as follows: pH:8.2, endotoxin: ${\leq}$ 0.5 EU/mg, ECP: ${\leq}$ 1.4 ppm, IEF: same removal distance, hGH content by Native-PAGE: 100%, purity by HPLC: ${\geq}$ 99%, yield by UV scanning: 87 to 89%, hGH monomer protein content by HPLC: 99%. Therefore, the final anion chromatography process was successfully validated in this study, and this method consistently yielded hGH solutions that satisfied pre-established criteria for subsequent processing.


  • 주제어

    validation .   recombinant human growth hormone(r-hGH) .   acceptance criteria .   anion exchange chromatography.  

  • 참고문헌 (25)

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