Table 2.

Summary of qualification results for linearity, accuracy, Limit of Quantitation (LOQ), and Limit of Detection (LOD).

	Linearity and Range				Accuracy
	R2	Range	LOQ, from calibration curve, 10 (SD/S)	LOD, from calibration curve, 3.3 (SD/S)	Level	% Recovery	% CV
CDR isomerization (%)	0.9995	4.1 – 65.7	3.3	1.1	Low	107.0	1.7
					Middle	99.0	0.4
					High	100.0	0.8
CDR deamidation (%)	0.9981	3.2 – 10.7	1.2	0.4	Low	106.0	0.3
					Middle	102.0	0.9
					High	103.0	0.5
PENNY deamidation (%)	0.9996	2.5 – 50.1	2.6	0.8	Low	103.0	1.7
					Middle	101.0	2.9
					High	99.0	0.9
Met-252 oxidation (%)	0.9977	3.1 – 46.2	4.8	1.6	Low	104.0	3.9
					Middle	96.0	2.4
					High	100.0	0.0
HL trisulfide bond (%)	0.9970	2.0 – 11.1	1.6	0.5	Low	96.0	0.6
					Middle	105.0	4.5
					High	103.0	8.8
HL thioether bond (%)	0.9979	0.5 – 13.6	1.4	0.5	Low	96.0	1.1
					Middle	106.0	0.1
					High	102.0	2.6
Cys-214 free thiol (%)	0.9936	0 – 3.1	0.6	0.2	Low	160.0	3.6
					Middle	99.0	1.3
					High	104.0	6.0
Afucosylation (%)	0.9917	8.3 – 31.4	6.7	2.2	Low	99.0	0.9
					Middle	98.0	0.3
					High	101.0	0.4