Abstract
Objective To compare purification effects on human coagulation factor Ⅷ(FⅧ) between polyethylene glycol(PEG) precipitation and ion exchange chromatography. Methods Three batches of FⅧ each were purified with PEG precipitation and ion exchange chromatography, respectively. Each quality index test was carried out according to Chinese pharmacopoeia 2015 (volume Ⅲ). The recoveries and relative quality indexes of FⅧ purified by 2 purification processes were compared. Results The recoveries of FⅧ purified by PEG precipitation and ion exchange chromatography were 29.90% and 68.25%, respectively. The specific activity and the tributyl phosphate residual amount of final FⅧ product were 3.8 IU/mg and 4.0 μg/ml with PEG precipitation, and 61.8 IU/mg and 0.8 μg/ml with ion exchange chromatography. Conclusion FⅧ purification with ion exchange chromatography can improve FⅧ quality effectively, and is more suitable for large scale production. Key words: Factor Ⅷ; Chromatography, ion exchange; Chemical precipitation
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