In this Ardena Insight, we examine the growing role of oligonucleotides (ONTs) as therapeutic agents and the analytical strategies supporting their development. Since the approval of the first ONT drug in 1998, the field has rapidly advanced, with most market approvals occurring in the past four years.
ONTs combine features of both chemical and biological drugs, posing distinct development challenges, from selective tissue targeting to potential immunogenicity. While preclinical safety evaluation often follows small molecule guidelines, ONTs may trigger immune responses, requiring additional assessments. Their quantification in biological matrices also demands techniques commonly used for biologics.
At Ardena, we apply industry-standard methodologies to assess plasma concentration, tissue distribution and immunogenicity, ensuring robust support for your oligonucleotide development programs.
