Analysis of therapeutic oligonucleotides Meeting regulatory expectations for drug quality

摘要

The complex and diverse nature of oligonucleotides currently in deveiopment [antisense, immunostimulation, siRNA, microRNA, aptamers, etc.) is posing unprecedented challenges in meeting the regulatory requirements for drug Quality. In spite of two approved oligonucleotide drugs, there is currently no regulatory guideline that specifically addresses this class of therapeutics. This artic'e provides an overview of the most relevant techniques for the cnalysis of various classes o*" oligonucleotides towards meeting reguatory expectations of drug cuaiity in the US, Canadc and Europe.