Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launch of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay, developed by SSB’s subsidiary BioOutsource and offered in combination with its unique Antibody Dependent Cell Cytotoxicity (ADCC) assay platform, combines data on the molecular structure with a key therapeutic mechanism of action. This will generate comprehensive, highly accurate biosimilar comparability data, driving shorter drug development timelines.
The new N-Glycan Assay is one of a range of orthogonal methods, including analysis by CD16a (FcγRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suitable for regulatory submissions.
BioOutsource’s new assay involves enzymatically-removing glycans from the antibody, functionally derivatizing them and separating the glycans by UHPLC. The glycans are then identified by on-line electrospray ionization mass spectrometry (ESI-MS), ...
