Essay On Deamidationminor N

Purification Process Design Purification Process DesignTypical Purity TargetsPrimary Product Species                                > 95 %Product Related Species (Biologically Active)        <  5 % totalOxidation (MetSO)DeamidationMinor N- or C-Terminal TruncationReversible AggregationCovalent Aggregate                                        <  0.1%Unrelated Species                                                <  0.1% eachNucleic Acid                                                        < 100 pg/doseEndotoxin                                                        < 1 EU/mgAdventitious Microbe                                        noneAdventitious Virus                                                noneChromatography  ModesResinCapacity(mg/ml)Cost($/L)Cleaning RegimenLifespan(cycles)Load ConditionElute ConditionCationExchange20-100Capture 500 Polish 30001) 1N NaAcetate2) 1N NaOH100-1000Low-physiologic Salt, pH at least 1 unit below.