Biophysical and biochemical characterization of peptide and protein drug product

INTRODUCTION Classes of Biotherapeutics The biotherapeutics class of drugs that are commercially available encompass a range of compounds including recombinant or purified proteins, monoclonal antibodies (also proteins), peptides, conjugated or fused peptides, antibody conjugates, protein vaccines, oligonucleotides, protein-lipid complexes, enzymes, antibody fragments (Fabs), glycosylated proteins, and carbohydrates (Fig. 1). Additional molecule types are in preclinical and clinical development.