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Table1
Comparisonbetweenautomatedandmanualprocessofthequalityofpuri?edmAbs.
AutomatedprocessManualprocess
aa
Recovery[%]Aggregates[%]Monomeric[%]Endotoxin[EU/mg]Recovery[%]Aggregates[%]Monomeric[%]Endotoxin[EU/mg]
mAb155.40.399.71.453.31.198.90.6
mAb2660.399.3<0.861.61.198.9<0.5
mAb380.60.499.6<0.568.40.299.8<0.3
mAb459.30.199.9nd42.81.188.3nd
mAb537.00.199.9nd27.90.499.6nd
mAb671.10.399.7<0.448.90.399.7<0.3
mAb767.60.191.8<0.440.80.191.2<0.3
mAb885.30.999.1<0.763.51.798.3<0.5
nd:notdetermined.
a
The?nalrecoveryrepresentsthepercentageofmAbmeasuredinthepuri?edfractionsbyNanodrop(A)tothatmeasuredintheunclari?edCBbyIPCasdescribed
280nm
inSection2.4.
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