Physicochemical and Biological Characterization of a Biosimilar Trastuzumab

Table 4

Monomer content of trastuzumab by SE-UPLC and CGE-NR. Variation is presented as confidence intervals at 95% ().

Product	Batch	SE-UPLC (%)	CGE-NR (%)
Trastuzumab-Probiomed	TZPP11002	99.6 ± 0.0	92.3 ± 0.3
	TZPP12001	98.9 ± 0.0	90.8 ± 1.1
	TZPP11001	99.4 ± 0.0	96.6 ± 0.4
Reference product	N3597B013	98.9 ± 0.1	92.8 ± 0.6
	N35973	99.7 ± 0.0	93.5 ± 0.7
	B34310	99.5 ± 0.0	93.1 ± 0.4