The formulation of biopharmaceutical products

Biopharmaceutical products represent a diverse group of products that includes proteins, peptides, nucleic acids, whole cells, viral particles and vaccines. The conformation of the macromolecule or cell must be maintained to retain biological activity, and animal models for biological activity and characterization assays are often developed in tandem with initial formulation studies. This presents the formulation scientist with a unique set of challenges when compared to those for small molecules. This review focuses on approaches to the formulation of macromolecules into biopharmaceutical products, and provides examples of studies that have been undertaken within the authors’ laboratories.