Oligonucleotide
- Oligonucleotides, i.e., polymers of nucleic acids, are an emerging class of therapeutics with a few FDA approved drugs and many more under intensive development. Oligonucleotide modalities have the premise to reach 'undruggable' targets. Antisense oligonucleotides (ASOs), small interfering RNAs (siRNA), micro RNAs (miRNAs), and aptamers are the main drug candidates. Oligonucleotides are not small molecules and require unique sets of bioanalytical expertise and experience to support their discovery and development activities. Quantitative measurement of oligonucleotides in biological matrices can be performed with either ligand-binding (LBA) or chromatographic methodologies, which are complimentary. Chromatography-based approaches include LC-UV, LC-FL, and LC-MS. Detailed attributes and comparisons of both approaches can be found in the eBook and Tech Talk from the following.
- Dr. Li has extensive experience in the development, qualification, and validation of chromatographic based approaches for the bioanalysis (discovery and regulated) of oligonucleotides in various biological matrices including plasma, urine, CSF, and different types of tissues. Please ask how we can help you develop oligonucleotide-based therapies with expertise in discovery and regulated oligonucleotide bioanalysis!
eBook on Chromatography Approaches for Bioanalysis of Oligonucleotides
Tech Talks: Cell and Gene Therapy Series
References for Bioanalysis of Oligonucleotides via LC-MS
- eBook. Eric Tewalt and Fumin Li. Ligand-binding and chromatographic methodology comparison and synergies for the pharmacokinetic bioanalysis of therapeutic oligonucleotides. An eBook in Bioanalysis Zone, 2021.
- Tech Talks: Cell and Gene Therapy Series Bioanalysis of Oligonucleotides: Ligand Binding and Chromatography Eric Tewalt and Fumin Li Tech Talks: Cell & Gene Therapy Series (pharmtech.com)
- Noah Post, Dennis Kraus, Ivy Smith, Eric Tewalt, Sarah Greenlee, John Matson, and Fumin Li. Quantitation of a GalNAc-Conjugated Antisense Oligonucleotide (ASO) and its Deconjugated Species via LC-MS/MS and hECL: A Comparison of Two Technologies. A poster presented at 69th ASMS Conference on Mass Spectrometry and Allied Topics, Philadelphia, PA, USA, Oct 31 - Nov 4, 2021.
- Dennis Kraus, Noah Post, Shannon Hall, and Fumin Li. Metabolite Profiling and Identification of an Antisense Oligonucleotide (ASO), Deconjugated ASOs, and Chain-Shorted ASOs from Human Plasma using IP-LC-UV-MS. ASGCT 23rd Annual Meeting, Virtual Format, May 12-15, 2020.
- Dennis Kraus, Noah Post, Shannon Hall, Shabana Khan, and Fumin Li. Metabolite Profiling and Identification of an Antisense Oligonucleotide (ASO), Deconjugated ASOs, and Chain-Shorted ASOs from Human Plasma using IP-LC-UV-MS. A poster presented at 68th ASMS Conference on Mass Spectrometry and Allied Topics Reboot, June 1 - 12, 2020.
- Ying Peng, Noah Post, Moo-young Kim, Shabana Khatri, Shannon Hall, and Fumin Li. Strategies for Bioanalysis of an Oligonucleotide and Chain-Shorted Metabolites from Human Plasma Employing LC-UV/MS/MS Detection. A poster presented at 67th ASMS Conference on Mass Spectrometry and Allied Topics, Atlanta, GA, USA, June 2 - 6, 2019.