By Brian Heasley, PhD, Director, Process Chemistry, Cambrex
As early as the 1920s, when isolated insulin was first used as a replacement therapy, peptides have been acknowledged as a valuable class of pharmaceutical compounds for their ability to promote natural therapeutic pathways. Despite their desirable profile combining high selectivity with low toxicity, technological advances in peptide synthesis have only recently caught up to provide manufacturing methods to meet demand. Now, CDMOs can draw upon multiple synthesis strategies to offer large-scale production of peptide APIs across a wide range of therapeutic applications.
A notable example demonstrating the promise of large-scale production of peptides was the launch of Fuzeon, a large 36-mer peptide involved in HIV-1 fusion inhibition, which was produced on commercial scale by a process involving solid phase peptide synthesis (SPPS). Pricing of Fuzeon may have hindered its success in the market, which is an inherent issue with SPPS: it is difficult to scale up without excessive cost. The requirements for specialized equipment, excess reagents and starting materials, additional purification steps, and other factors, all add up to increased cost of production.