As synthetic oligonucleotide therapeutics gain increasing interest for drug products, having efficient methods for determining their impurity profiles is critical, especially as these synthetic oligonucleotides increase in length and complexity. Currently established HPLC-MS (single Quad) methods for analyzing impurities can be time consuming and require manual processing steps that introduce the risk of human error and create challenges with implementation in a regulated setting. Here, we show how the BioAccord LC-MS System can be used with integrated waters_connect™ Informatics to streamline the analysis of impurities. The tools integrated into this data analysis workflow are intended to reduce user burden and facilitate the analysis of synthetic oligonucleotide impurity profiles of increasing complexity.The live version of this recording took place during the USP Workshop on Therapeutic Peptides and Oligonucleotides: Regulations and Quality Standards on April 9-10, 2024.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations