Resolving acidic or basic variants that may influence stability or bioactivity
29 Apr 2026
Quality Control & Characterization
- Which acidic and basic variants are present, and what are their underlying root causes (e.g., deamidation, glycation, C-terminal lysine, sialylation)?
- How can analytical methods best separate, identify, and quantify these variants with sufficient resolution and confidence?
- Which variants measurably impact stability, potency, or bioactivity—and where is the clinical relevance threshold?
- How do process conditions (cell culture, purification, formulation, storage) drive formation or interconversion of charge variants over time?
- What control strategies (process tuning, purification polishing, formulation changes) most effectively reduce or manage problematic variants while maintaining yield?