ABSTRACT

The term “biopharmaceuticals” is used to describe biotechnologically derived drug products. Biopharmaceuticals are protein-based macromolecules and include, insulin, human growth hormone, the families of the cytokines and of the monoclonal antibodies, antibody fragments, and nucleotide based systems such as antisenseoligonucleotides, siRNAandDNApreparations for gene delivery. These are large complexmolecules and are often heterogeneous mixtures compared to synthetically manufactured, pure small molecules. This chapter focuses only on protein molecules.