Glycan Profiles of FDA-Approved Therapeutic Antibodies: Insights from Regulatory Submissions - PubMed
3 hours ago
- #Therapeutic Antibodies
- #Glycosylation
- #FDA Regulatory Submissions
- Glycan characterization data from 209 FDA-approved BLAs shows ten predominant Fc N-glycans in IgG antibodies, with six common across CHO, NS0, and Sp2/0 cell lines.
- Low-abundance afucosylated glycans (<10%) are tightly controlled in drug substance specifications for antibodies with Fc effector functions, though acceptance criteria vary by product.
- Glycan profiles depend on the expression system: CHO-derived antibodies feature human-compatible structures, while NS0 and Sp2/0 introduce non-human epitopes; Fc fusion proteins have higher branching and sialylation than conventional IgGs.
- Product labels describe Fc effector functions only as in vitro observations or proposed mechanisms, with limited clinical validation, highlighting the need for better correlation between in vitro assays and clinical outcomes.