Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab

Table 3

Deamidation and oxidation modifications of HS628 and originator tocilizumab.

	Modification site	Modification type	Mass signal intensity (%)
			HS628; (20130901)	HS628; (20130902)	HS628; (20130903)	HS628; (20130904)	Originator tocilizumab; (B2014B10)
Heavy chain	N(77)QFSLR	Deamidation	5.2	4.2	3.8	3.9	3.7
	DTLM(254)ISR	Oxidation	2.5	1.5	1.9	1.8	3.3
	FNWYVDGVEVH; N(288)AK	Deamidation	22.6	21.8	20.6	20.5	21.4
	VVSVLTVLHQDWL; N(317)GK	Deamidation	99.8	99.7	99.8	99.6	99.7
	GFYPSDIAVEWES; N(386)GQPENNYK	Deamidation	75.6	82.6	74.9	76.6	75.5
	WQQGNVFSCSVMHE; ALHN(436)HYTQK	Deamidation	6.7	7.7	6.7	6.2	6.8
Light chain	ASQDISSYLN(34)WYQQKPGK	Deamidation	1.9	2.5	1.5	1.9	1.6
	SGTASVVCLL; N(137)NFYPR	Deamidation	44.4	37.8	34.2	35.4	41.5
	SGTASVVCLLN; N(138)FYPR	Deamidation	5.9	5.5	4.7	4.9	5.8