Senior Principal Scientist Novartis Biomedical Research East Hanover, New Jersey
This presentation will commence with a brief overview of the advancement of antisense oligonucleotide (ASO) drugs over the past two decades. The subsequent segment will discuss the challenges encountered in LC-MS method development for ASO bioanalysis. The topics covered will include sample preparation, chromatography, and instrumentation techniques aimed at achieving high selectivity while meeting stringent sensitivity requirements. A double liquid-liquid extraction (LLE) method was employed to extract NVS001 from human plasma with high recovery, and ion pairing mobile phases were utilized to retain polyanionic charged molecules on the column with optimal ionization efficiency. This LC-MS/MS method has been validated in accordance with regulatory guidance.
Learning Objectives:
Upon completion, participant will be able to understand the challenges encountered in the method development for bioanalysis of ASO (sample extraction and LC-MS);
Upon completion, participant will be able to understand the requirements of high sensitivity and high selectivity in bioanalysis of ASO
Upon completion, participant will be able to understand current techniques and future developing perspectives
