Best Practices in Formulation and Lyophilization Development (Proteins, mAbs and ADCs)
By Simtra
The goal of formulation development is a stable product, and a well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
This paper looks in detail at development approach, analytical toolboxes, formulation development, and more, showing how best practice can guide development of a formulation that can be lyophilized.