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 kD 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. TM 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