Bioanalysis of oligonucleotides by HPLC-MS/MS in support of regulatory submission has not been widely adopted. Several obstacles such as lack of sensitivity, adduct formation and analytical instrument dedication are barriers that many laboratories are unwilling to challenge. In order to increase the sensitivity of the method, analysis was conducted using microflow HPLC (MFLC) conditioned for oligonucleotide analysis thus reducing adduct formation. The microflow system is on a portable cart that allows the scientist the ability to transport the pumps to any mass spectrometer available without allocating an entire LC-MS/MS system for oligonucleotide analysis. HPLC-MS/MS analysis is an alternative approach to ELISA and qPCR analysis providing better selectivity, increased dynamic range and the flexibility to analyze a vast array of oligonucleotides from any biological matrix.

About the Presenter

Chad has over 20 years of related experience as an analytical scientist with over 17 years focused on bioanalysis at Alturas Analytics. This depth of experience in applied LC–MS/MS and GC–MS/MS, along with an education in chemical engineering provides the backbone for productive and innovative science. Chad leads the biologics quantitation group at Alturas, applying novel techniques to a regulated, high-throughput production environment. As a Senior Principal Scientist, Chad’s primary focus is LC–MS/MS method development, validation, and sample analysis for small new chemical entities, oligonucleotides, biologics, and antibody drug conjugate (ADC) programs in accordance with GLP guidelines. In addition, Chad leads a team of scientists as Study Director and Principal Investigator, providing technical oversight to clients across all therapeutic areas.