Proceedings of the PSK Conference (대한약학회:학술대회논문집)
- 2002.10a
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- Pages.329.2-330
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- 2002
Studies on standardization and characterization of recombinant interferon alia
- Kim, Gi-Hyun (Korea Food and Drug Administration) ;
- Shin , Won (Korea Food and Drug Administratio) ;
- Jung , Ja-Young (Korea Food and Drug Administratio) ;
- Park, Young-Ju (Korea Food and Drug Administratio) ;
- Joung , Jee-Won (Korea Food and Drug Administratio) ;
- Oh, Il-Ung (Korea Food and Drug Administratio) ;
- Jin, Jae-Ho (Korea Food and Drug Administratio) ;
- Kim, Seo-Mi (Korea Food and Drug Administratio) ;
- Jung , Sang-Mi (Korea Food and Drug Administration)
- Published : 2002.10.01
Abstract
This study was intended to establish test methods equivalent to those of "Interferon alfa-2 concentrated solution" monograph in European Pharmacophoeia(EP). Two recombinant interferon alfa concentrated solutions manufactured in Korea were tested according to the monograph of EP. Tests of identification(biological activity. isoelectric focusing. SDS-PAGE under reducing condition, peptide mapping). related proteins. impurities of moducular masses differing from that of interferon alfa-2(SDS-PAGE under reducing and non-reducing condition). bacterial endotoxin, protein, potency, host-cell-derrved proteins. and host-cell-derived DNA were performed in the laboratories of manufacrues and division of biotechnology. KFDA. The results of this study showed that specitications of interfenon alfa concentrated solutions manufactured in Korea were within the aceptance criteria of EP. Based on the study. specitications and test methods for interferon alfa concentrated solution can be established according to the monograph of EP suggesting the revision of Minimum requirements for biological products
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