Course Description:
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.
Who should participate:
- Regulatory scientists
- Analytical scientists
- Quality assurance analysts
- R&D scientists and managers
- Quality control analysts
- Contract research organizations
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 and features a presentation by Ying Qing Yu.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.