Overcoming unusual challenges in the characterisation of a monoclonal antibodies by LC-MS from early to late stage of development
Different modalities of monoclonal antibodies are pushing the limits of characterisation by MS, therefore new critical quality attributes need to be carefully monitored from developability in early phases as well as during process development and clinical phases.
Several case studies, all addressed using X500B QTOF System from SCIEX, will illustrate the first stages of antibody development as well as the support it provides to process and product understanding with the characterisation of unusual modifications (such as sulfation, additional glycosylation), and of structural heterogeneity with both traditional methods as well as native SEC-MS method.
Séverine Clavier, Deputy Head of Structural Analysis Lab, Sanofi R&D
Séverine did a PhD and postdoc in Proteomics and joined Sanofi in September 2015.
Armelle Martelet, Deputy Head of Structural Analysis Lab, Sanofi R&D
Armelle did a PhD in proteomics, had a 4-year experience in Stallergenes-Greer and joined Sanofi in October 2017.
Both are working as deputy head of the structural analysis mass spectrometry lab which is part of the BioAnalytics department of the BioPharmaceutics Development platform