Course Description:
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.
Who should participate:
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
- Student
The live version of this recording took place on during the USP Workshop on Therapeutic Peptides and Oligonucleotides:
Regulations and Quality Standards on March 2, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker:
Kui Yang, Ph.D.
Senior Research Scientist
Division of Complex Drug Analysis, Office of Testing & Research, OPQ, CDER
US FDA