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Wu F.,Indiana University Bloomington | Chabenne J.R.,AIT Bioscience | Gelfanov V.M.,Indiana University Bloomington | Mayer J.P.,Indiana University Bloomington | DiMarchi R.D.,Indiana University Bloomington
Journal of Peptide Science | Year: 2015

This report describes the chemical synthesis and biological characterization of novel three-chain insulin analogs with a destabilized secondary structure. The analogs, obtained by chemical synthesis via a single-chain precursor and selective enzymatic digestion, were used to investigate the role of the highly conserved 'insulin fold'. Biological characterization through in vitro biochemical signaling showed extremely low activity at each insulin receptor when compared with native insulin. We conclude that the 'insulin fold' is a structural foundation that supports insulin biological action. Copyright © 2015 European Peptide Society and John Wiley & Sons, Ltd.

Lowes S.,Quintiles | Hucker R.,A4P Consulting Ltd. | Jemal M.,931 Edinburg Road | Marini J.C.,Janssen Research and Development LLC | And 7 more authors.
AAPS Journal | Year: 2014

The A2 harmonization team, a part of the Global Bioanalysis Consortium (GBC), focused on defining possible tiers of chromatographic-based bioanalytical method performance. The need for developing bioanalytical methods suitable for the intended use is not a new proposal and is already referenced in regulatory guidance language. However, the practical implementation of approaches that differ from the well-established full validation requirements has proven challenging. Advances in technologies, the need to progress drug development more efficiently, and emerging new drug compound classes support the use of categorized tiers of bioanalytical methods. This paper incorporated the input from an international team of experienced bioanalysts to surmise the advantages and the challenges of tiered approaches and to provide recommendations on paths forward. © 2014, American Association of Pharmaceutical Scientists.

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