Abstract
The degree of monoclonal antibody galactosylation is known to affect complement-dependent cytotoxicity (CDC) activity by affecting C1q binding, suggesting that galactose is associated with CDC bioactivity. However, whether this association also exists under temperature stress conditions is not known. This study highlights the impact of variations in the terminal galactose content of an anti-CD20 monoclonal antibody on CDC bioactivity under high-temperature stress conditions compared with storage conditions at 2–8 °C. Drug product samples with a total galactose content of >38% showed stable CDC bioactivity at higher temperatures (45 °C), while those with 16% galactose content showed reduced CDC activity.
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