Verification of the Final Anion Exchange Chromatography in the r-hGH Manufacturing Process
- Authors
- Min, Byeong Jo; Kang, Seong Woo; Song, Yoon Seok; Lee, Jong Ho; Lee, Seung Heon; Park, Chulhwan; Kim, Seung Wook; Kim, Chan-Wha
- Issue Date
- 5월-2010
- Publisher
- KOREAN SOC BIOTECHNOLOGY & BIOENGINEERING
- Keywords
- validation; recombinant human growth hormone (r-hGH); acceptance criteria; anion exchange chromatography
- Citation
- BIOTECHNOLOGY AND BIOPROCESS ENGINEERING, v.15, no.3, pp.488 - 496
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- BIOTECHNOLOGY AND BIOPROCESS ENGINEERING
- Volume
- 15
- Number
- 3
- Start Page
- 488
- End Page
- 496
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/116481
- DOI
- 10.1007/s12257-009-3053-9
- ISSN
- 1226-8372
- Abstract
- 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: <0.6 EU/mL, bioburden test: negative. Final anion exchange chromatography was conducted using a DEAE Sepharose FF Resin and eluted with a linear gradient of 30 to 110 mM NaCl in 50 mM Tris-HCl buffer at a flow rate of 15 L/h. Three consecutive batches of hGH solutions were generated via anion exchange chromatography, which was performed within pre-established operating parameters determined through in-process control. When all three batches were assessed by the pre-established sampling plan and tested for quality control, this purification process was shown to satisfy pre-established acceptance criteria; endotoxin: <= 0.5 EU/mg, ECP: <= 1.4 ppm, IEF: same removal distance, hGH content by Native-PAGE: 100%, purity by HPLC: >= 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.
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- Appears in
Collections - College of Engineering > Department of Chemical and Biological Engineering > 1. Journal Articles
- College of Life Sciences and Biotechnology > Division of Life Sciences > 1. Journal Articles
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