Effects of ionic strength and sugars on the aggregation propensity of monoclonal antibodies: Influence of colloidal and conformational stabilities

The authors, of Daiichi Sankyo and Osaka University, present a strategy for optimizing monoclonal antibody formulations via a combination of dynamic light scattering (DynaPro Plate Reader), electrophoretic mobility (Mobius), analytical ultracentrifugation, differential scanning calorimetry and turbidity along with calculations of the electrostatic potential surface. The k_D values obtained from dynamic light scattering are found to correlate well with accelerated stability tests, while the electrophoretic mobility provides important insights as to the mechanism behind colloidal stability. T_M correlates with freeze-thaw induced aggregation.

Saito, S.; Hasegawa, J.; Kobayashi, N.; Tomitsuka, T.; Uchiyama, S.; Fukui, K. Pharmaceutical Research  2013, 30, 1263-1280. DOI: 10.1007/s11095-012-0965-4