TABLE III

H₂O₂ Decomposition Rate Comparison Between Different mAb Formulations

Monoclonal Antibody Formulation (concentration)	Initial Target H₂O₂ Concentration (ng/mL)	Remaining H₂O₂ Concentration During −70°C Storage (ng/mL)		Remaining H₂O₂ Concentration During −20°C Storage (ng/mL)		Remaining H₂O₂ Concentration During 2–8°C Storage (ng/mL)
Monoclonal Antibody Formulation (concentration)	Initial Target H₂O₂ Concentration (ng/mL)	7 Days	28 Days	7 Days	28 Days	7 Days	28 Days
WFI	50	38	54	12	19	58	63
mAb A (30 mg/mL)	50	47	54	33	12	42	22
mAb C (200 mg/mL)	50	44	33	<LOD^a	<LOD	<LOD	<LOD
WFI	100	76	79	20	29	100	113
mAb A (30 mg/mL)	100	90	108	69	26	78	45
mAb B (60 mg/mL)	100	106	122	39	<LOD	65	17
mAb C (200 mg/mL)	100	118	75	<LOD	<LOD	11	<LOD
WFI	250	203	247	107	105	226	257
mAb A (30 mg/mL)	250	223	273	162	74	179	125
mAb C (200 mg/mL)	250	229	205	26	<LOD	39	<LOD