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.

Subject area:
Biologics

Objectives (If applicable):
na

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations