Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
News|Articles|December 15, 2023
Development of a Standardized, Kit-Based Approach for Selective and Reproducible Sample Preparation and Extraction for Therapeutic Oligonucleotides from Biological Matrices
Author(s)Waters
This app note reviews the development of the OligoWorks SPE Microplate Kit and detergent-free protocol for oligonucleotide bioanalysis and demonstrates performance across a broad range of chemically diverse oligonucleotides, including GalNAc and lipid-conjugated species. The analytical testing and screening work to optimize the protocol for high recovery and low matrix effects is discussed in detail and LC-MS data is presented for spiked plasma and urine samples showing excellent inter and intra-kit, day-to-day and user-to-user reproducibility (RSDs ≤15%).
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