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By Nathalie Y. Toussaint and John Champagne

Nathalie Toussaint-finalJohn Champagne-finalAs we read the healthcare news headlines, we are left asking: are peptides really the next big thing? Peptides and small proteins are receiving heightened press within professional sports and the cosmetic industry, but they are also probing interest among pharmaceutical scientists. Peptide therapeutics is a rapidly evolving scientific field, with the addition of unnatural amino acids, stabled peptides, and alternate routes of administration leading the way. The Transparency Market Research report of 2014 projects peptide revenue for 2018 to grow to over 25 million U.S. dollars. Nonetheless, peptide therapeutics are not considered novel and have a long history of being used to control, trigger, and maintain physiological processes. Still, one of the major challenges to peptide and small protein therapeutics is the stability over their shelf life.

Peptide stability can be broadly classified as chemical stability, referring to modifications of peptide or protein via chemical bonds, or classified as physical stability, including self-association (mass action and non-mass action aggregation), changes in secondary and tertiary structure, and adsorption to surfaces. Physical instability is considered a major issue since it can lead to altered bio-performance product quality concerns and immunogenicity.

The 2015 AAPS Annual Meeting and Exposition will offer an exciting short course Characterization Methods for Aggregates and Particles in Peptide and Small Protein Formulations. Come learn about physical instability challenges for peptide therapeutics and characterization methods with applicability in the academic lab and industrial settings from discovery though commercial characterization. This short course will have the added benefit of providing a broad overview on peptide stability and characterization methods followed by in depth sections on various analytical methods, relevant case studies, roundtable discussions, and regulatory perspective on biophysical phenomena in peptide and small protein formulations. It is designed to be a teaching session for pharmaceutical scientists and provide a collaborative, cross-disciplinary forum for scientific discussion.

Nathalie Y. Toussaint, Ph.D. is a principal scientist in discovery pharmaceutical sciences at Merck Research Laboratories in Kenilworth, NJ. She is a member of AAPS and has served on various sections including PPB, Biotec, and SPOD sections.
John Champagne, Ph.D., is a senior applications scientist and northeast regional manager for Wyatt Technology; he currently runs the applications lab for Wyatt Technology in the Boston area and provides both sample analysis and customer support services. He graduated with a M.S. and Ph.D. from the Biochemistry Department at the University of New Hampshire, under the advisory of professor Thomas Laue.