Phase Appropriate Approach for Formulation Development

The requirements and general set-up for a therapeutic protein formulation are changing during the lifecycle of a development project.
The development of a protein formulation for the pre-clinical and early clinical phase is determined by a limited molecule and process knowledge, low drug substance quantities and competitive development timelines for entry-into-human. Nevertheless, the resulting clinical service form should allow a flexible dosing regimen and demonstrate sufficient stability during drug product manufacturing, storage, shipping and administration. Therefore, a platform formulation strategy is often chosen in order to handle a high number of development programs.
A commercial successful protein therapeutic requires a thorough understanding of the physical and chemical behavior of the individual protein. The characterization of the formulation design space leads to a robust protein formulation which needs to be compatible to large-scale manufacturing processes. Furthermore, the increasing medical need for patient compliant home-use therapeutics creates additional challenges such as compatibility with device technology and additional requirements with respect to stability at ambient condition.
The presentation will point-out the differences in formulation strategies between early and late-stage development phases and will explain the specific challenges with help of several case studies.