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. Our Pace Life Sciences Boston, MA development site 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