Abstract: Provided herein are methods of determining product quality of an antibody composition, wherein the product quality is based on the Fc? receptor II (Fc?RI) binding level of the antibody composition. In exemplary embodiments, the method comprises (a) determining the afucosylated glycan content and/or ?-galactosylated glycan content of a sample of the antibody composition; (b) optionally, calculating a predicted Fc?RII binding level based on the afucosylated glycan content and/or ?-galactosylated glycan content as determined in (a); and (c) determining the product quality of the antibody composition as acceptable when (i) the afucosylated glycan content and/or ?-galactosylated glycan content is within a target range and/or (ii) the predicted Fc?RII binding level is within a target range. Related methods of monitoring product quality and methods of producing an antibody composition are further provided herein.

Abstract: Multi-capillary systems for high-throughput electrophoretic separation and detection of biomolecules are disclosed. One embodiment of the invention uses galactomannans as a size-sieving matrix for multi-channel electrophoretic separations of biomolecules. Multi-color detection for the simultaneous analysis of controls and standards in the same channels as the samples, and endogenous fluorescence detection are also disclosed. Another embodiment of the invention is a two dimensional system for separation of complex samples, using multiplexed capillary electrophoresis system as the second dimension, with a fraction collection step connecting the two separation steps. The systems allow for separations to be accomplished with a highly parallel manner, or in a two-dimensional format.