Figure 10 — Analytical platforms and the attributes each one characterises.
Each platform answers a specific question about a biologic's identity, purity, or activity.
Figure 10 — Analytical platforms and the attributes each one characterises.
Aggregates and fragments, charge variants, identity, and peptide mapping.
Size heterogeneity and charge profile.
Host cell protein, binding assays, and potency.
Residual host cell DNA to regulatory limits.
Concentration and conformational assessment.
Cell-based potency assays and bioassay work.