Verification of the final anion exchange chromatography in the r-hgh manufacturing process

Byeong Jo Min, Seong Woo Kang, Yoon Seok Song, Jong Ho Lee, Seung Heon Lee, Chulhwan Park, Seung Wook Kim, Chan Wha Kim

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)488-496
Number of pages9
JournalBiotechnology and Bioprocess Engineering
Issue number3
Publication statusPublished - 2010 Jun


  • Acceptance criteria
  • Anion exchange chromatography
  • Recombinant human growth hormone (r-hGH)
  • Validation

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology
  • Biomedical Engineering


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