Process Development for Purification of Therapeutic Antisense Oligonucleotides by Anion-Exchange Chromatography

This article describes the development of an anion-exchange chromatography method for purification of phosphorothioate antisense oligonucleotides. A variety of operating conditions were studied and optimized at small scale. These optimized parameters were used to generate data at multigram scale. The selected method can give a high purity product at a very good yield of the full-length desired product. This method can be suitably scaled up for antisense oligonucleotide purification at large scales.