Our developability assessment expertise helps identify the physical and chemical properties of drug candidates, such as aggregation, post-translational modifications, stability, and solubility, that can negatively impact the safety, efficacy, manufacturability and ultimately the success of clinical candidates. Our approach combines in silico modeling, stress, stability and concentration tests. Our clients can enter the preclinical space with the knowledge of process parameters to mitigate liabilities that cannot be engineered out of the molecule, to help avoid costly and time-consuming formulation development efforts, and clinical failures with appropriate control strategies.
We provide our clients the tools and understanding to achieve successful protein characterization and process development in a phase-appropriate manner. We offer a broad range of analytical testing capabilities including protein mass, protein titer, protein stability as well as protein integrity and structure determination. Aragen offers binding affinity assays, enzyme activity assays, cell-based assays and a host of in vivo efficacy testing assays.