International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.

The later may relate to potential variations in some quality attributes of the “in house” reference standards that may be significant for ADCC, but may not have such an effect on other rituximab bioactivities, i.e., different glycosylation profile may affect ADCC activity as described before, 37,38 but may be less likely to affect CDC activity or target cell binding. 39,40 The higher intra-laboratory variability (7–36%) for ADCC compared to CDC, cell-based binding or apoptosis assays (3–17%) may also reflect specific challenges of the ADCC bioassay.

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