Table VI

Drug Product Quality Analysis for mAb A1 Mixed Using LevMixer, Magnetic Mixer, and Mobius Mixer at Low Tip Speed (0.84 m/s)

Mixer	Duration (min)	Size Variants by SEC (%)				Turbidity^{^a}	Particle Analysis by HIAC Royco (particles/mL)
Mixer	Duration (min)	Mixing	HMWS	Monomer	LMWS	Turbidity^{^a}	≥2 μm	≥5 μm	≥10 μm	≥15 μm	≥25 μm
Control 1A	0	No	1.7	98.2	0.2	0.088	52	23	12	4	0
LevMixer (128 rpm)	0	No	1.7	98.0	0.3	0.086	29	8	1	0	0
	30	Yes	NT	NT	NT	0.087	40	11	1	1	1
	60	Yes	1.7	98.2	0.2	0.069	74	22	3	0	0
Magnetic Mixer (100 rpm)	0	Yes	1.7	98.0	0.3	0.064	16	7	1	0	0
	30	Yes	1.7	98.2	0.2	0.075	58	23	8	2	1
	60	Yes	1.7	98.2	0.2	0.071	436	109	27	3	1
Control 1B	60	No	1.7	98.2	0.2	0.079	25	13	2	0	0
Control 2A	0	No	1.9	98.0	0.1	0.085	40	20	7	3	1
Mobius Mixer (50 L; 240 rpm)	0	Yes	1.7	98.1	0.2	0.073	194	58	13	4	1
	30	Yes	NT	NT	NT	0.080	13	6	3	0	0
	60	Yes	1.9	98.0	0.1	0.068	57	22	10	6	4
Control 2B	60	No	1.9	98.0	0.1	0.086	19	7	1	0	0

NT, not tested; HMWS, high molecular weight species; LMWS, low molecular weight species; SEC, size exclusion chromatography.
↵a Turbidity measured at average absorbance 340–360 nm.