Bioanalytics – Chemical
Nucleic acid therapeutics have significant potential to address diseases that historically have been challenging to treat with small molecule drugs or biologics. Chromatographic and immunoassay (LC-MS and HELISA) methods are most commonly used to support bioanalysis during preclinical and clinical development of oligonucleotide therapeutics. In this session, a comparison of LCMS bioanalytical methods for quantitation of oligonucleotides with HELISA methods in various biological matrices will be drawn to demonstrate that a balance of selectivity and sensitivity for quantitation of nucleic acid can be achieved using combinatorial approaches. Method development challenges, solutions and performance of both methods for quantitation using a representative stereopure oligonucleotide will be shared. The decision-making process for the selection of bioanalytical methods to support preclinical/clinical programs will be discussed with the help of case studies.