Formulation characterization - biologics

Formulation Characterization

The characterization of protein or peptide conformation in a formulation can be important since: 1) structural changes might not be readily reversible and could diminish activity and 2) formation of intermolecular interactions might induce the formation of aggregates. The analysis of protein conformation in a formulation can be a serious challenge, for instance due to obscuration by excipients. With the access to an array of analytical tools, we have the possibility of not only analyzing the conformation of released proteins/peptides, but in many cases also carrying them out in situ. Thus, knowledge about the structural integrity of biomacromolecules in a formulation can help excluding unsuitable formulations and thereby save time in later development stages.