Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls
Chapter 6: Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturing
Published:16 Aug 2019
E. R. Lax and T. Shah, in Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls, ed. V. Srivastava, The Royal Society of Chemistry, 2019, ch. 6, pp. 151-193.
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The outlook for peptide therapeutic drugs is bright. The range of medical indications is expanding and the rate at which peptide therapeutic drugs are being approved is increasing. New formulations and alternative delivery modalities are overcoming many of the inherent weaknesses of peptide-based pharmaceuticals. From many perspectives, peptide therapeutics are benefiting from the success of biologics. However, the sustainability of independent contract manufacturing of peptide-based new chemical entities (NCEs) for approved products and candidates in clinical trials is open to question given the consolidation in the industry over the last 20–30 years. At present, this specialized type of manufacturing activity is performed by only a few companies. This chapter analyzes the causes of the consolidation and examines the current economic and environmental issues that affect peptide therapeutic manufacturing.