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.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
