Analytical characterization of ch14.18: a mouse-human chimeric disialoganglioside-specific therapeutic antibody.

ABSTRACT: Ch14.18 is a mouse-human chimeric monoclonal antibody to the disialoganglioside (GD2) glycolipid. In the clinic, this antibody has been shown to be effective in the treatment of children with high-risk neuroblastoma, either alone or in combination therapy. Extensive product characterization is a prerequisite to addressing the potential issues of product variability associated with process changes and manufacturing scale-up. Charge heterogeneity, glycosylation profile, molecular state and aggregation, interaction (affinity) with Fcγ receptors and functional or biological activities are a few of the critical characterization assays for assessing product comparability for this antibody. In this article, we describe the in-house development and qualification of imaged capillary isoelectric foc

SUBMITTER: Soman G 

PROVIDER: S-EPMC3338943 | biostudies-literature | 2012 Jan-Feb

REPOSITORIES: biostudies-literature