Mechanisms for Protein Aggregation and Stabilization in Solution, during Freezing and Drying, and at Interfaces

Description

Damaging stresses to proteins occur at all stages of the life history of protein drug product, from manufacturing to delivery to the patients. To develop safe and effective protein products, it is critical to understand the mechanisms for aggregation and particle formation, and the mechanisms for protein stabilization against the wide range of stresses encountered. This presentation will focus on: the pathway for protein aggregation; the physical factors governing protein aggregation in bulk solution; the mechanisms for stabilization of proteins in solution, during freezing and during dehydration; the mechanism for protein particle formation during interfacial stresses; and the mechanisms by which surfactants inhibit this degradation.

These insights are important for key areas including: candidate molecule screening and selection, formulation development, manufacturing, drug delivery and investigating “surprising” appearance of unacceptable visible particles.