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Beyond mRNA: how advances in analytical techniques are enabling a revolution in the RNA drug landscape

Beyond mRNA: how advances in analytical techniques are enabling a revolution in the RNA drug landscape

Currently, there are 3 main types of in vitro transcribed (IVT) RNA drugs. Two of these—conventional messenger RNA (mRNA) and base-modified mRNA (bmRNA), which incorporates chemically modified nucleotides—are non-replicating. The third type is self-replicating RNA (srRNA), which is based on an engineered viral genome but devoid of viral structural protein genes. Its self-replicating ability makes srRNA a promising tool for new therapeutic drugs.

Overcoming N-nitrosamine analysis challenges with mass spectrometry and chromatography solutions

Overcoming N-nitrosamine analysis challenges with mass spectrometry and chromatography solutions

N-nitrosamine analysis has raised significant concerns in the pharmaceutical industry since 2018, when these potential carcinogens were found in several angiotensin II receptor blockers (sartans). Subsequent discoveries in ranitidine and some slow-release metformin medications prompted widespread product recalls. The industry has implemented stricter manufacturing requirements and intensified efforts to evaluate and control N-nitrosamine contamination. To meet stringent regulatory requirements, it is essential to develop effective chromatography and mass spectrometry (MS) methods for N-nitrosamine analysis. This blog addresses the challenges associated with detecting N-nitrosodimethylamine (NDMA) in metformin drug products.