One of the primary challenges in synthetic oligonucleotide drug development and application review is the imprecision of commonly used analytical methods in adequately resolving complex impurities and accurately determining their levels to ensure the identity, strength, purity and quality of synthetic oligonucleotide products.
The presentation will describe a high resolution mass spectrometry (HRMS)-based analytical method and include a few case studies that address coeluting isobaric impurities, a challenging scenario in oligonucleotide impurity profiling. Custom synthesized oligonucleotides including the intended full-length sequence containing commonly used modifications, and isobaric impurities of similar molecular masses are used in the method development and analytical capability demonstration.

Subject area:
Biologics

Objectives (If applicable):
NA

Target Audience (If applicable):
QA Manager
QA Staff
QC Chemist
QC Manager
R&D
Regulatory
Student