Executive Summary
Proteins and peptides fulfill an irreplaceable role as medicines due to their high affinity, specificity, low toxicity, and ability to alter protein-protein interactions. They are widely recognized as therapeutic agents in the treatment of a variety of conditions, including diabetes, osteoporosis, non- Hodgkin’s lymphoma, and leukemia. Clinical development is on-going as the pharmaceutical industry works to harness the potential of peptides for many other conditions. While incredible progress has been made in designing peptide and protein-based drugs for multiple therapeutic uses, challenges remain. This paper explores challenges of peptide and protein-based new chemical entities [NCEs] including potential chemical and physical instabilities, enzymatic degradation, and their rapid elimination from circulation.
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