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A 2-fold revolution: MS approaches for the bioanalysis of oligonucleotide therapeutics

A 2-fold revolution: MS approaches for the bioanalysis of oligonucleotide therapeutics

In 1998, the US Food and Drug Administration (FDA) approved fomivirsen as the first therapeutic oligonucleotide therapeutic. This approval marked a revolution of mechanism of action discovered decades before finally coming to fruition. Since then, the landscape of chemical modifications of oligonucleotides, conjugations and formulations has evolved tremendously, contributing to improvements in stability, efficacy and safety. Today, more than a dozen antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) drugs are on the market, most of which are designated as orphan drugs for treating rare genetic diseases.

Supporting new CRISPR gene editing systems

Supporting new CRISPR gene editing systems

Prime editing (PE) is a next-generation gene editing technology that utilizes a Cas9 protein fused to a prime editing guide ribonucleic acid (pegRNA) to achieve high CRISPR/Cas9 editing efficiency and precision. However, the length requirement of pegRNAs at 120–250 nucleotides (nt) and their high level of secondary structure formation present analytical challenges for the purity analysis of chemically synthesized pegRNAs during development and quality control (QC).

Guide decisions during cell line development with more information at the intact level

Guide decisions during cell line development with more information at the intact level

Monitoring product quality attributes (PQAs) throughout monoclonal antibody (mAb) development is vital to ensuring drug safety and efficacy. By adopting orthogonal analytical techniques and integrating new technologies that have the potential to provide more information, it is possible to improve product quality and manufacturing efficiency and make more informed decisions.

Maximize NPS analysis with accurate mass spectrometry

Maximize NPS analysis with accurate mass spectrometry

LC-MS/MS is a powerful analytical tool in forensic toxicology testing that can support a variety of testing regimes such as screening, confirmation and quantitative workflows. More specifically, analysis of NPS using LC-MS/MS provides many advantages, including the ability to reliably detect new drugs and their metabolites from a variety of biological matrices.

Unlock the benefits of nominal mass spectrometry for NPS analysis

Unlock the benefits of nominal mass spectrometry for NPS analysis

The development of analytical methods for the detection and quantitation of drugs and metabolites in a range of biological matrices is a challenging process. Forensic toxicology labs need a reproducible and reliable methodology to ensure the robustness of the data and the quality of the results. They also need robust and sensitive instrumentation that can detect drugs at trace levels with high specificity, especially when it comes to novel psychoactive substances (NPS), which can be difficult to monitor and control.

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