Developability failures often emerge during the purification, concentration, storage or handling of a biologic candidate, at a point when starting over is both costly and time-intensive. Our platform directly tests candidates under relevant solution and stress conditions, providing critical insights early and de-risking the path from candidate to clinic.
Conformational stability, colloidal stability, aggregation, fragmentation, charge heterogeneity, subvisible particles, solubility, self-interaction and viscosity are assessed using orthogonal methods. Forced degradation studies reveal sensitivity to temperature, agitation, freeze-thaw, oxidation and pH. For multiple candidates, predefined criteria enable transparent ranking. The result is a comprehensive experimental risk profile with clear recommendations for candidate selection, formulation work, and further development.
