Applications for oligonucleotide therapeutic analysis

Thermo Fisher Scientific offers optimized solutions for the accurate and robust analysis of oligonucleotide therapeutics, a critical class of biotherapeutics. These solutions encompass a range of applications that enable the confirmation of identity and determination of purity, quality, and strength. For more detailed information on these specific applications, please refer to the sections below.


LC-HRAM MS approaches for characterization and monitoring of therapeutic oligonucleotide impurities

In recent years, numerous chromatographic techniques have been developed and utilized for the detection and measurement of impurities in oligonucleotide therapeutics. However, these approaches have faced limitations due to their lack of selectivity. In this context, we propose a more efficient method that leverages Thermo Scientific Orbitrap-based LC-HRAM MS platforms for the comprehensive characterization and monitoring of impurities in therapeutic oligonucleotides.

 

This approach capitalizes on the unique capabilities of high-resolution accurate mass (HRAM) and data-dependent tandem mass spectrometry (ddMS2). By employing these techniques, we can confidently identify, map, and quantitate oligonucleotides, impurities, and degradation products in a single experiment. This streamlined approach not only enhances the accuracy and reliability of analysis but also offers a more time-efficient and cost-effective solution for quality control in the development of oligonucleotide therapeutics.

Streamlining characterization and monitoring of oligonucleotide impurities using an Orbitrap-based LC-HRAM-MS platform

A variety of chromatographic techniques for detecting and quantifying product-related impurities in oligonucleotide therapeutics have been reported. However, chromatographic approaches alone still suffer from an inherent lack of selectivity. Here we present a streamlined approach using Orbitrap-based LC-HRAM MS platforms for characterization and monitoring of therapeutic oligonucleotide impurities.

Identification and quantitation of oligonucleotides, impurities, and degradation products

The capabilities of high-resolution accurate mass (HRAM) and data-dependent tandem mass spectrometry (ddMS2) enable confident identification, mapping, and relative quantitation of oligonucleotides, impurities, and degradation products in a single experiment. View examples in our application note.


Expanding oligonucleotide UV quality control methods (QC) with MS

The advancement of oligonucleotide UV quality control methods has been significantly enhanced by the integration of mass spectrometry (MS). Integrating MS in an existing UV workflow can provide additional information in the same amount of time via an efficient, easy-to-use interface for MS control and data processing.

 

Additionally, a workflow can be streamlined from sample, sequence, data generation, data processing, all the way to reporting through the implementation of compliance-ready Thermo Scientific Chromeleon Chromatography Data System on a UHPLC-UV-MS system.

Oligonucleotide characterization for quality control and increased productivity by single quadrupole mass spectrometer with extended mass range

View our app note to learn how expanding a UV QC method with MS provides mass confirmation and impurity identification.

Automated, compliance-ready, intact mass confirmation of modified oligonucleotides using an LC-MS platform

A fully automated workflow from sample to report for the compliance-ready intact mass confirmation of a set of five phosphorothioated oligonucleotide samples.


LC-UV characterization of oligonucleotides

Effective separation of oligonucleotides demands a column with high throughput and resolution, as well as the capability to perform under varying pH levels, temperatures, and mobile phase compositions. The column should have a wide pore size to allow efficient separation of large nucleic acids, and the chemistries should minimize carry-over.

DNAPac RP Column - High Performance Reversed-Phase Chromatography Column for Oligonucleotides and Large Double-Stranded

The Thermo Scientific DNAPac RP HPLC column is designed for analysis of oligonucleotides and double-stranded (ds) DNA/RNA fragments using LC/UV or LC/MS, providing excellent performance under a broad range of pH, temperature, and mobile phase compositions.

Ultra-high-resolution anion exchange LC-UV characterization of oligonucleotides

When oligonucleotide purity and characterization is critical to your work, you can rely on our anion exchange and reversed phase column chemistries.

Oligonucleotide purification using Thermo Scientific DNASwift HPLC Columns

The use of oligonucleotides in therapeutic and diagnostic research is rapidly expanding. DNA and RNA oligonucleotides for these areas of research must be of the highest purity. The Thermo Scientific DNASwift monolith column is specifically designed to provide exceptionally high-resolution, laboratory-scale purification of DNA and RNA oligonucleotides by anion-exchange chromatography.