Oligonucleotides

The entire area of oligonucleotide-based drugs are receiving much higher business activity since the approval of Isis' Vitravene. As this is still a relatively new area,  the quantitation of oligonucleotide-based drugs in any biological matrix is not as well established as small organics or proteins and vaccines.

QPS uses both chromatographic and ligand binding methods for quantitation of oligonucleotide-based drugs. For chromatographic methods, we have used the traditional LC-MS/MS, as well as LC/UV assays to examine plasma exposure. QPS scientists will work with your development team to determine specific study parameters. The choice of detection and quantitation and whether to use chromatographic or LBA is based on the primary structure, the number of monomeric units and the desired study design. Hybridization assay is used when higher assay sensitivity (lower LLOQ) is needed for PK analysis.