Abstract

The complex and diverse nature of oligonucleotidescurrently in development (antisense, immunostimulation,siRNA, microRNA, aptamers, etc.) is posing unprecedentedchallenges in meeting the regulatory requirements for drugquality. In spite of two approved oligonucleotide drugs, thereis currently no regulatory guideline that specifically addressesthis class of therapeutics. This article provides an overview ofthe most relevant techniques for the analysis of various classesof oligonucleotides towards meeting regulatory expectationsof drug quality in the US, Canada and Europe.