Removal of DNA contaminants from therapeutic protein preparations.
Mammalian cell culture-derived biotechnical products for therapeutic use have risks associated with cell substrate DNA. Regulatory authorities in the USA and Europe have set stringent limits for this contaminant, requiring orders of magnitude reduction from fermenter harvests to purified products. This paper addresses the relevant unit processes (e.g., cell separation, affinity chromatography and ion-exchange chromatography) utilized for purification of mammalian cell culture-derived products as they pertain to removal of DNA contaminants.
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Biochemical R&D, Pharmaceutical Division, Miles Inc., Berkeley, CA 94701.
Mitra
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D002469:Cell Separation; D002846:Chromatography, Affinity / Q000379:methods; D002850:Chromatography, Gel; D002852:Chromatography, Ion Exchange; D004247:DNA / Q000302:isolation & purification*; D005285:Fermentation; D011506:Proteins / Q000302:isolation & purification* / Q000627:therapeutic use
D011506:Proteins; D004247:DNA