Essay About Deamidationminor N And Physiologic Salt

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 isoelectric pointHigh Salt or increased pHAnionExchange20-100Capture 500 Polish 30001) 1N NaAcetate2) 1N NaOH100-1000Low-physiologic Salt, pH at least 1 unit above isoelectric pointHigh Salt or decreased pHHydrophobic Interaction2-101000-25001) Urea2) 1N NaOH50High Precipitating Salt [1M (NH4)2SO4]Low Salt, or Miscible Organic (ethylene glycol)ReversedPhase5-202000-5000High Organic(0.1% TFA, 100% Acetonitrile)50Low Organic(0.1% TFA, 10% Acetonitrile)Intermediate Organic(0.1% TFA, 50% Acetonitrile)MetalAffinity5-501000-25001) EDTA 2) 1N NaOH100Neutral pH, 1M NaClAmmonium Chloride or GlycineProtein-AAffinity20-3010000High Salt or GuHCl100-300Neutral pH, 0.15M NaCl1M Acetic Acid pH 3GelFiltration400-10000.5N NaOH50Concentrated~2-fold Dilution