Bioanalysis Zone

Oligonucleotide and mRNA therapeutics: bioanalytical challenges and lessons learned





Oligonucleotides and mRNA therapeutics add complexity to therapeutic drug development, giving rise to new challenges for bioanalytical development activities. During this presentation, we will review these challenges and present several case studies for both chromatographic methods (LC-MS/MS and LC-UV/fluorescence) and ligand binding assays (hybridization ELISA and Luminex®/Quantigene® platforms) for the determination of oligonucleotides and mRNA in biological matrices.

What will you learn?

  • Chromatographic approaches and reviews of case studies
  • Challenges that arise using various platforms for both chromatographic methods and ligand binding assays
  • The differences between hybridization ELISA and the Luminex®/Quantigene® platforms so you know when each is preferred
  • How to develop sensitive assays (single digit pg/mL) that are analyte, species and matrix independent
  • Critical factors including matrix interference, the one-assay-fits-all methodology, and sensitivity

Who should attend?

  • Bioanalytical scientists focusing on oligonucleotide and mRNA therapeutic drug development
  • Outsourcing scientists
  • Analytical development scientists (CMC) who would like to learn more about platform challenges
  • Senior level executives working within: immunoassay services; biologics services; pharmacodynamic services; pharmacokinetic services; immunogenicity services; toxicology-pharma development



Jamil Hantash
Technical Director
Tandem Labs


Mr Hantash is the Technical Director for Immunoanalytical Services in our New Jersey laboratory. He comes to Tandem Labs with 15 years of CRO experience supporting pre-clinical and clinical large molecule drug development. Prior, Mr Hantash was with Pharmanet/i3 where he worked as the Director of Operations in Immunochemistry. He also served as Senior Laboratory Manager of Immunochemistry and Immunology at Covance Laboratories. He has held senior positions in the areas of immunochemistry, drug metabolism, and immunology at Merck Research Laboratories, Millipore/EMD, and Charles River Laboratories.

Laixin Wang
Associate Laboratory Director
Tandem Labs


Dr Wang directs all method development activities in the Utah facility. His expertise includes the synthesis, formulation, and bioanalysis of oligonucleotide and peptide therapeutics. After receiving a Ph.D. in medicinal chemistry at Beijing Medical University in 1992 with a thesis on the synthesis of modified oligonucleotides as anticancer agents, Dr Wang focused on the delivery/formulation of antisense and ribozyme oligonucleotide drugs at the University of Utah, and developed a new method for the synthesis of oligonucleotide arrays (DNA chips) at Duke University.

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