Please join the AAPS Bioanalytical Community on December 5th@ 12:00 pm EDT for an Open Scientific Discussion:
Current Strategies and Advancement in Quantitative Bioanalytical Oligonucleotide Methodologies
Oligonucleotides, which are nucleic-acid polymers that can range from ~10-50 base pairs, have been undergoing research and development as potential therapeutics for over three decades. Over that span of time, considerable advances have been made to increase the half-life of oligonucleotides via modifications and advances in drug delivery. Due to the advances being made in oligonucleotide development and delivery, expansion of oligonucleotide modalities, and increased volume of oligonucleotides being developed as therapeutics, an appropriate bioanalytical strategy must be implemented for the quantification of oligonucleotides. The importance of an appropriate bioanalytical strategy is amplified by the generated data being utilized to assess pharmacokinetic (PK) and drug metabolism (DM), as well as biodistribution. Current methodologies used extensively to quantitate oligonucleotides include chromatographic platforms, such as UPLC-UV, LC-FL, LC-MS/MS, and LC-HRAM, and ligand-binding assays (LBA) such as hybridization enzyme-linked immunosorbent assays (ELISA) and electrochemiluminescent (ECL) assays. Here we will discuss current strategies and advances in both chromatographic and ligand binding methodologies to quantitate oligonucleotides in pre-clinical and clinical studies and how they may be utilized to create a synergistic approach for oligonucleotide PK/DM assessments.
Moderator: Sanjeev Bhardwaj (Moderna)
Long Yuan – Biogen
Eric Tewalt – PPD, part of Thermo Fisher Scientific
Troy Voelker – Aliri Bioanalysis
Have an idea for an upcoming session?
Please contact the OSD Committee Co-Chairs, @Sanjeev Bhardwaj & @Laurelle Calliste
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