Stabilization and Aggregation of Biopharmaceuticals

In order to engineer high-concentration protein formulations (HCPFs), the addition of excipients is typically required to increase the protein solubility and stability. Frequently used excipients in the (bio)-pharmaceutical industry include: amino acids, salts, sugars, polymers, and surfactants that already have a Food and Drug Administration (FDA) approval [1,2]. The selection of suitable excipients for development of HCPFs is commonly performed on the basis of heuristics (“trial and error”) and is carried out by high-throughput screening methods [3]. Within this work, suitable excipients and their potential will be identified based on a mechanistic understanding of the underlying molecular interactions. Based on the investigations and characterization of interactions (e.g. light-scattering analytics, physical models), it’s the aim of this work to predict thermodynamic properties of aqueous protein solutions. This will lead to a reduction in time and experimental effort in investigations of suitable protein formulations.