Oligonucleotide Analytical

Analytical characterization plays an important role in ensuring product integrity and manufacturing consistency, which are essential for demonstrating safety and efficacy to the FDA and other regulatory authorities. However, the unique charge and polymeric structure of oligonucleotides makes the analytical characterization particularly challenging. Selection of appropriate analytical techniques depends on the molecule size, higher order structure and chemical composition/modifications. Wolfe Laboratories uses a suite of analytical methods to assess the physicochemical and biophysical properties of oligonucleotides, including mass spectrometry-based techniques, chromatographic techniques, electrophoresis, particulates analysis and hybrid techniques, as summarized in the following table.

Attribute Technique
Identity HRMS, IP-RP-LC, cSDS, IEX cIEF
Purity IP-RP-LC, LC-MS, cSDS, IEX
pI/Charge Variants cIEF, IEX
Size/Aggregation DLS, MALS, SEC
Concentration UV-Vis, Fluorescence
Sequence Confirmation LC-MSMS fragmentation