Technology Summary

Liquid formulations of therapeutic proteins require storage at high concentration and must remain stable for 2 years for FDA approval. Drug formulation is hindered by slow and inaccurate tests for predicting a drug’s shelf life. This technology offers high-throughput and accurate predictions of colloidal stability in therapeutic protein formulations that will reduce formulation screening time from 1 month to 1 day. Current prototypes employ two thermoelectric cooling plates – across which the samples loaded in glass capillaries are placed – to form a temperature gradient across the samples, and dark-field microscopy is used to image the samples. Image analysis is used to extract key thermodynamic and kinetic parameters from the images for each experiment. The figure above shows a mAb solution at various time points (left) and schematically depicts the stages of phase separation (right).