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- Title
Analytical Separation Methods for Therapeutic Oligonucleotides.
- Authors
Vanhinsbergh, Christina Jayne
- Abstract
The therapeutic oligonucleotide industry continues to grow due to increasing regulatory approvals and improvements in medicinal chemistry. The term oligonucleotide therapeutic encompasses a diverse range of oligonucleotide molecular structure and function. Among the types of oligonucleotide therapeutic are antisense and splice-switching oligonucleotides, short interfering RNA (siRNA), aptamers, messenger RNA (mRNA), antagomirs, and immunomodulatory oligonucleotides. Oligonucleotides function to manipulate the expression of proteins associated with disease states or pathogenicity. Currently there are 10 approved pharmaceuticals on the market. The diverse nature of oligonucleotide therapeutics leads to the requirement for multiple separation methods to characterize quality attributes. Chromatographic separation is required for post manufacturing purification, characterization of impurities and structural variants, pharmacokinetic studies, and analysis of drug formulations. As oligonucleotide therapeutics are highly chemically-modified to improve efficacy and resilience to nucleases, they are challenging to analyse using a single method. Multiple chromatographic separations can overcome challenges of broad peak shapes and low resolution between closely related analytes. In addition, mass spectrometry (MS) detection enables higher accuracy when characterizing complex samples.
- Subjects
MESSENGER RNA; MOLECULAR structure; PHARMACEUTICAL chemistry; MASS spectrometry; PROTEIN expression; OLIGONUCLEOTIDES
- Publication
LC-GC Europe, 2020, Vol 33, Issue 10, p20
- ISSN
1471-6577
- Publication type
Article