Complementary Methodologies For Analysis Of NISTmAb Impurities

Understanding size heterogeneity is essential for ensuring the quality and safety of monoclonal antibody therapeutics. This resource explores how two complementary analytical techniques—size‑exclusion chromatography (SEC) and CE‑SDS—work together to deliver a complete picture of high‑ and low‑molecular‑weight impurities in the NISTmAb reference standard. SEC offers reliable quantification of monomer levels and aggregate species under native conditions, while CE‑SDS reveals detailed fragmentation patterns and accurately measures low‑molecular‑weight variants that SEC often underestimates. By comparing results from both approaches, discover where each technique excels and why combining them leads to a more confident characterization of antibody integrity.

Access the full application note to see side‑by‑side data and methodology details.