Conference poster examining analytical assessment aligned with the EMA product specific bioequivalence guidance using a range of orthogonal techniques.
Lanreotide, a synthetic octapeptide analogue of somatostatin, self-assembles into monodisperse nanotubes in aqueous formulations. EMA product-specific guidance outlines how bioequivalence for lanreotide acetate can be demonstrated through orthogonal analytical characterisation of molecular, structural, and thermodynamic properties.
In this poster, we show how techniques including DSC, FTIR, optical microscopy, and Cryo-TEM can be applied to characterise self-assembled lanreotide acetate formulations and support bioequivalence assessment.
Originally presented at the 3rd LNP Characterization & Analytical Development Summit | Boston, MA
Authors: Tharshini Vinayahan, Shaun M. Smith, Kieran Millett, Daniel Cassim, Christopher McMahon, Intertek Pharmaceutical Services
Download the poster to learn how comprehensive in vitro characterisation can align with EMA expectations for generic peptide development.
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