Rational design of freeze-drying formulations: a Molecular Dynamics approach

Even though freeze-drying is widely used for the preparation of biopharmaceuticals, it causes stresses which can result in unfolding or aggregation. Suitable excipients must therefore be added to avoid loss of activity. However, at present, the choice of a suitable formulation is mainly empirical, due to a lack of knowledge about the phenomena involved. In this context, the objective of the present work was to understand the molecular mechanisms at the basis of protein stabilization, and to guide the choice of suitable excipients.