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Analysis of therapeutic oligonucleotides
Meeting regulatory expectations for drug quality

G. SUSAN SRIVATSA1*, MING FAI CHAN2
*Corresponding author
1. ElixinPharma, P.O. Box 231989, Encinitas, California 92023, USA
2. Accugent Laboratories, Inc., 5933 Sea Lion Place, Suite 105, Carlsbad, California 92010, USA

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.


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