Physicochemical and Biological Characterization of a Biosimilar Trastuzumab

Table 5

Relative abundance of trastuzumab subunits by CGE-R. Variation is presented as confidence interval at 95% ().

Product	Batch	HC %	NGHC %	LC %
Trastuzumab-Probiomed	TZPP12001	66.18 ± 0.16	0.57 ± 0.06	32.89 ± 0.19
	TZPP12002	64.46 ± 0.47	0.58 ± 0.02	34.59 ± 0.32
	TZPP12003	65.45 ± 0.97	0.50 ± 0.05	33.53 ± 1.08
Reference product	B3393B019	65.14 ± 0.25	0.57 ± 0.03	33.93 ± 0.13
	B3417B010	66.02 ± 0.27	0.52 ± 0.09	33.04 ± 0.25
	B3430	66.40 ± 0.25	0.63 ± 0.01	32.46 ± 0.16

HC: heavy chain, NGHC: nonglycosylated heavy chain, and LC: light chain.