Course Description:
A significant challenge in the development, manufacturing, and regulatory evaluation of both new and generic synthetic oligonucleotide drugs is the limitation of commonly employed analytical techniques. These methods are often inadequate to effectively resolve, characterize, and quantify complex oligonucleotide impurities. Advances in oligonucleotide analytical methods can improve impurity characterization and facilitate the assurance of the identity, strength, purity and overall quality of oligonucleotide drug products.
A LC-high resolution mass spectrometry (HRMS)-based Multi-Attribute Method for Oligonucleotides (MAMO) has been developed to address shortcomings in available methodologies. MAMO is designed to enable simultaneous detection, identification and profiling of product-related impurities within a single platform. This method streamlines oligonucleotide characterization (accurate mass, sequencing) and quality control testing (identity, assay, purity, and impurities).
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 Kui Yang. Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.