ARCs or Antibody-RNA Conjugates have become a highly useful and versatile tool for delivery of siRNA therapeutics and provide several advantages to naked siRNA therapy. The bioanalysis of these complex molecules requires consideration of all aspects of the conjugate and payload siRNA as well as varied matrices that will be necessary for comprehensive interpretation of study data. Using commonalities among ARCs and proven approaches melding both large molecule (ligand binding) and small molecule (LCMS) platforms, it is possible to design reproducible and effective approaches to both nonclinical and clinical bioanalysis. This discussion is intended to provide insights into learnings across conjugated and unconjugated siRNAs to utilize resources and platforms in cost- and time- effective ways.
Learning Objectives:
understand common frameworks for ARCs and how they are used to frame bioanalytical approaches
understand current requirements and multi-platform approaches for nonclinical and clinical bioanalysis of ARCs
evaluate their own ARC programs for areas in which efficiencies can be proactive sought for cost and time savings
