The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
Development Approach
In new product development for proteins, monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), it is common for the phase 1 and final commercial product presentation to be undetermined. Liquid, frozen liquid and freeze-dried solid formats may all be under consideration pending stability outcomes. Despite this uncertainty, clinical trials should be performed with a formulation representative of the final product. An appropriate freeze-dried formulation is always suitable for a frozen liquid and liquid formulation, but the inverse is not true. Therefore, end-in-mind development of a formulation that can be lyophilized, even if a liquid is used for phase 1 studies, results in overall faster timelines and lower risk.
Development Approach
In new product development for proteins, monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), it is common for the phase 1 and final commercial product presentation to be undetermined. Liquid, frozen liquid and freeze-dried solid formats may all be under consideration pending stability outcomes. Despite this uncertainty, clinical trials should be performed with a formulation representative of the final product. An appropriate freeze-dried formulation is always suitable for a frozen liquid and liquid formulation, but the inverse is not true. Therefore, end-in-mind development of a formulation that can be lyophilized, even if a liquid is used for phase 1 studies, results in overall faster timelines and lower risk.