Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs

By Jayasree M. Srinivasan, Ph. D.

This white paper explores best practices for formulation development, with a focus on creating stable pharmaceutical products. A key strategy for enhancing product stability is the use of lyophilization, a freeze-drying process that often offers the highest likelihood of technical success. Lyophilization involves freezing the formulation, then subjecting it to a vacuum to remove frozen ice and any remaining unfrozen water, preserving the drug’s integrity.

This technique is a critical tool in drug manufacturing, especially for products sensitive to moisture. As the science behind pharmaceutical freeze-drying advances, the process continues to evolve, driven by an improved understanding of product characteristics, precise control over process conditions, and innovations in equipment efficiency. Learn more about how these advancements are helping to optimize the stability, efficacy, and shelf life of pharmaceutical products by downloading the white paper below.