Resolving Non-Parallelism in a Phase 3 HCP Assay

Challenge: A late-stage program's HCP ELISA showed non-parallel dilution curves between reference standard and process samples, threatening a regulatory submission timeline.

Approach: Root-cause investigation identified a coverage gap between the antibody reagent and the process-specific HCP population; a targeted antibody re-selection and assay re-optimization closed the gap.

Outcome: Parallelism was restored within the program's submission window, with no disruption to the filing timeline.