Course Description:
Standard approaches to LC separation of oligonucleotides include an ion pair, an acid modifier and a C18 column. Attempts have been made to optimize the separation of the full-length product (FLP) and impurities but typically fall short as methods require overloading of highly purified products to observe impurities which can create confounding data. This is further complicated by utilization of nominal mass spectrometry systems that have difficulty in resolving confounding masses. This creates workflows that
require manual processing with subjective results based on the analyst performing the assay. Techniques which utilize a variety of stationary phase chemistries in line with a high-resolution mass spectrometer will be explored for the benefits they provide for streamlined oligonucleotide assays.
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:
Andrew Argo, M.S.
Scientist I, Analytical Development-Oligonucleotides
Biogen