Solid-phase synthesis is predominantly used today for the manufacture of oligonucleotide therapeutics. Impurities in the oligonucleotide API need to be tightly controlled and major impurities need to be characterized depending on the clinical stage of the program. This presentation discusses major classes of impurities and where they originate from such as raw materials, like phosphoramidites and the solid support, ancillary reagents, the synthesis process, and degradation.
Subject area:
Biologics
Objectives (If applicable):
N/A
Target Audience (If applicable):
QA Manager
QA Staff
QC Chemist
QC Manager
R&D
Regulatory
Student