The formulation is the "drug product".  In addition to ensuring the safety and efficacy profiles of the active product candidate by stabilizing it through the manufacturing, transportation, storage, and delivery processes, the integrity of the drug and its individual components also need to be optimized for clinical, commercial and regulatory needs.   In our formulation development studies for proteins, antibodies, and peptides, the composition of each excipient will be optimized to maximize the stability within the products' specific requirements.

Based on years of industrial experience, Integrity Bio has developed an efficient process to identify optimal formulations for biopharmaceuticals. With the study, formulations that are stable enough for various stages of development will be identified. In addition, experimental results to support the general stability profiling of each product will be generated.

The following examples show some of our capabilities in this area: