Ultrasensitive quantitation assay of oligonucleotide therapeutics based on the PALSAR method
Akane Omori, Koichi Shibusawa, Kazuhiro Takeuchi, Akira Ideno
Drug Development Solutions Center, Research & Development, SEKISUI MEDICAL CO., LTD. 2117 Muramatsu, Tokai, Ibaraki 319- 1182, Japan
Recently, development of oligonucleotide therapeutics has accelerated in the pharmaceutical industry, and the needs for ultrasensitive quantitation methods have greatly increased. Conventional approaches, such as hybridization, LC-MS/MS, PCR are used in the analysis. Hybridization is commonly used, yet sensitivity is insufficient. Sensitivity of LC-MS/MS is improved by instrumental advancement, but still not enough. PCR and qRT-PCR are also known as sensitive detection methods; however, the high variability of measured values is a problem. To solve these problems, we aimed to develop an ultrasensitive hybridization assay method without nucleic acid amplification procedure.