A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody

AAPS Open

Table 7 Comparison of the method sensitivity without or at different acid dissociation time

PC conc. (ng/mL)	No AA 100 μg/mL free drug			15 min AA 100 μg/mL free drug			30 min AA 100 μg/mL free drug			45 min mM AA 100 μg/mL free drug
PC conc. (ng/mL)	Signal	S/N	% Recovery mean	Signal	S/N	% Recovery mean	Signal	S/N	% Recovery mean	Signal	S/N	% Recovery mean
5000	1343	4.8	100.9	2579	9.2	103.0	2553	9.1	100.7	2855	10.2	103.4
2500	734	2.6	98.0	1182	4.2	95.7	1243	4.4	97.3	1332	4.7	94.1
1250	482	1.7	102.0	690	2.5	100.8	740	2.6	105.5	812	2.9	105.0
625	350	1.2	96.0	440	1.6	95.2	448	1.6	95.9	479	1.7	95.8
312.5	303	1.1	107.9	374	1.3	126.4	344	1.2	99.6	369	1.3	110.3
156.25	271	1.0	90.4	295	1.0	75.3	291	1.0	94.2	280	1.0	78.1
78.125	270	1.0	172.4	306	1.1	206.4	278	1.0	131.9	284	1.0	169.8
0	246	0.9		257	0.9		250	0.9		231	0.8

The bolded values indicate the row with the lowest PC conc which has a recovery ≥ 30%, defined as the sensitivity for each condition