Table V

Drug Product Quality Analysis for mAb A1 Mixed Using LevMixer, Magnetic Mixer, and Mobius Mixer at High Tip Speed (1.37 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 (210 rpm)	0	No	1.6	98.0	0.3	0.083	52	14	1	1	0
	120	Yes	NT	NT	NT	NT	136	48	13	4	2
	240	Yes	1.7	98.2	0.2	0.075	78	18	4	1	0
	480	Yes	1.7	98.1	0.2	0.073	70	29	9	3	1
Magnetic Mixer (165 rpm)	0	No	1.6	98.0	0.3	0.081	52	23	12	4	0
	120	Yes	NT	NT	NT	NT	1061	132	16	3	0
	240	Yes	1.7	98.2	0.2	0.069	982	35	4	1	0
	480	Yes	1.7	98.2	0.2	0.088	6528	959	35	6	1
Control 1B	480	No	1.7	98.2	0.2	0.063	8	3	2	1	0
Control 2A	0	No	1.9	98.0	0.1	0.084	78	32	13	2	2
Mobius Mixer (50 L;400 rpm)	0	No	1.7	98.1	0.2	0.069	14	3	1	1	1
	120	Yes	NT	NT	NT	NT	21	7	5	3	1
	240	Yes	1.6	98.2	0.2	0.070	13	4	3	1	1
	480	Yes	1.6	98.3	0.1	0.066	33	16	3	1	1
Control 2B	480	No	1.6	98.1	0.3	0.077	20	11	4	2	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.