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

In order to save precious drug substance and expedite the development process, we recommend a strategy of separately developing the clinical and commercial formulations. The preclinical/clinical formulation will be developed within a 3-6 month time frame to provide an initial formulation that is stable enough to support the development process up to Phase II clinical trials. The commercial formulation can then be developed or optimized while clinical studies are in progress.

Different types of formulations need to be developed based on clinical needs, patient compliance, delivery methods, drug stability, storage and distribution, and market competitiveness. Having a clear vision of the type of formulation that is desired will allow one to design better formulation studies. Liquid formulations have generally been preferred due to the convenience of manufacturing and ease-of-use for patients. However, many protein drugs may not be stable enough to be handled as a liquid formulation. Dried formulations, e.g., lyophilized formulations, or suspension formulations have been successfully used to overcome these stability problems. In addition, specific applications and/or delivery routes may demand or require a specific type of formulation processing such as a spray-dried formulation for pulmonary delivery systems. Multidose formulations are useful when the dose needs to be split for dose titration or dose combination.

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

Preformulation Characterization Studies
Protein/peptide Stabilization
Clinical Formulations for Phase I-II
Commercial Formulations for Phase III or later
Lyophilized Formulation
Multidose Formulation
Stability Studies
Degradation Products Characterization