Analytical developers and biomanufacturers working with immunoglobulin G4 (IgG4) monoclonal antibodies have long faced a critical gap: the absence of a true, high‑quality IgG4 reference material to anchor system suitability assessments and physicochemical characterization of their antibodies.
In this GEN webinar, our expert speakers will introduce USP mAb-004 Reference Standard, a new IgG4-specific reference material developed to support reliable method development and routine analytical performance monitoring. Unlike engineered or modified IgG4 therapeutics, USP mAb-004 maintains its native IgG4 structure, offering a realistic baseline for studying attributes such as hinge dynamics and half‑antibody formation—features that may be reduced or absent in stabilized variants. The webinar will explore how the USP mAb-004 Reference Standard enables drug developers to directly assess the impact of stabilizing mutations on Fab-arm exchange behavior and to evaluate multiple physicochemical attributes using a single, consistent standard.
Using examples from three case studies, attendees will learn the importance of:
- Characterizing IgG4 molecules with greater precision,
- Addressing persistent host cell protein (HCP) clearance challenges, and
- Streamlining workflows using a true IgG4‑specific benchmark
A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.
Produced with support from:
