WuXi TIDES – The Role of Benchmarking Critical Impurity Control in Therapeutic Oligonucleotide Phosphoramidites
The growing need for oligonucleotide therapeutics aimed at larger patient populations has driven the demand for high-quality nucleoside phosphoramidites – the building blocks for oligonucleotide therapeutics. To support the emergence of synthetic oligonucleotide therapeutics, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have recently provided more clarity in regulatory expectations. In 2024, the FDA published a guidance that described the clinical pharmacology requirements while the EMA’s guidance focused on manufacturing and control of synthetic oligonucleotides. The recent EMA guidance reiterated the principles per International Conference on Harmonisation (ICH). This guidance reinforces the regulatory expectations of analytical rigor and process robustness needed for starting m ... ...
