A Novel in vitro Serum Stability Assay for Antibody Therapeutics incorporating Internal Standards

Yihan Li, a Senior Scientist with Abbvie, discusses her team’s approach to screening large quantities of biologics before animal testing. They focus on identifying stable molecules by spiking biologics into various matrices, incubating them, and collecting samples over time. The purified samples are then analyzed using LC-MS to ensure stable recovery across the time points. Li emphasizes the importance of using an internal standard to correct operational errors and variations, which significantly improves data accuracy and quality.

The use of NISTmAb as an internal standard and its limitations, particularly when the target molecule has a similar molecular weight. Li explores the potential of using the Fc fragment of NISTmAb, which offers a different molecular weight, as a universal internal standard. The video concludes that incorporating an internal standard, whether NISTmAb or its Fc fragment, enhances the reliability of stability assessments for biologics. Findings are shown for 19 antibody therapeutics with promising indications for improving data consistency and accuracy in biologics screening.