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Balancing robust viral inactivation with product recovery

01 Sept 2026
Downstream Processing & Purification
  • How can molecule instability at low pH, including aggregation, fragmentation, or potency loss, be mitigated, particularly for IgM, IgA, and multispecific formats?
  • How can mixing and pH heterogeneity be controlled at scale to avoid local pH “hot spots” during acid addition and ensure consistent product quality?
  • How can process kinetics and control parameters such as time, temperature, and pH be managed to improve reproducibility and support successful scale-up?
  • How can neutralization-induced stress be minimized to prevent precipitation or further aggregation during rapid or uneven pH adjustment?
Industry Expert
Avneesh Saini, Senior Director CMC - Radiant Biotherapeutics