With recent introduction of several new Oligonucleotide based drugs to the market, an increased need for high quality analytics to support the process of registration emerged. This requires an in-depth understanding of the chemical structure of the final molecule. Here we provide examples on how NMR spectroscopy is used in our laboratory to support the chemical synthesis of Oligonucleotides by use of regular and chemically modified monomer building blocks. Additionally, we demonstrate how NMR based fingerprinting is used for confirmation of structural integrity and identity of such complex molecules which are often present as diasteriomeric mixtures. Finally, we provide an example for the application of quantitative NMR (qNMR) for definition of reference standards needed for UV-based quantitative analysis (e.g. Chromatography). Limitations of the method will be discussed.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations