Being the most prominent regulators of vital functions, peptides have always spurred much interest for therapeutic applications.
Nevertheless, their limited stability under physiological conditions has slowed down the development of peptide APIs. Tremendous progress made in the last decade, especially in the field of drug delivery systems, has led to a renewed interest in peptide APIs. There are today tens of commercial drugs based on a peptide active ingredient and more than one hundred peptides in clinical development.
In parallel, the commercial production of peptide APIs has also grown very strongly; it is now possible to produce hundreds of kilograms of peptide APIs under fully compliant cGMP conditions, even complex peptide sequences, for instance cyclic peptides, disulphide bridged peptides or sequences with non-natural amino acids. Both traditional routes of producing peptides chemically (so-called liquid phase synthesis and solid phase synthesis) have been improved to allow cost effective API production and support the development of very successful commercial drugs.
More recently, hybrid processes have been developed, whereby some fragments are made following a solid phase approach and the fragments are combined together using classical liquid phase chemistry, with a view to maximise cost efficiency for the production of a given peptide.
In conclusion, the two major obstacles for the development of peptide API's have been lifted : drug delivery systems overcome their inherent low bioavailability and proven, modern synthetic methods allow the production of large quantities cost effectively.
Today, peptides are clearly viable drug candidates. This time peptides are here to stay.
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Peptisyntha SA is based in Brussels, Belgium. www.peptisyntha.com
