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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.
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.
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.
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.
For Research Use Only. Not for use in diagnostic procedures.