Robustness of Hybrid LBA/LCMS Assays in a Regulated Environment

Presented at the 10th Workshop on Recent Issues in Bioanalysis (WRIB), this presentation outlines the incorporation and robustness of hybrid LBA/LCMS assays in a regulated environment. Download the presentation to learn how the incorporation of IA-based enrichment approaches to LCMS detection has led to many advancements in bioanalysis of protein therapeutics and biomarkers such as antibody-drug conjugates (conjugated "payload"), low abundance protein PD biomarkers, isotyping for anti-drug antibodies, signature peptide immunoaffinity for analysis of bound drug targets in tissue samples, and so on. There are challenges with the adaptation of these approaches to the outsourcing of the associated methods for high-throughput analysis for large clinical studies. This is a new frontier for CROs, as the complex techniques have little overlap with traditional small molecule drug extraction and detection strategies. IQVIA Laboratories is one of the few bioanalytical laboratories successfully employing immunoprecipitation techniques and multi-dimensional LC for the quantitation of biotherapeutics, peptides, proteins, and biomarkers. Our team has the experience and knowledge in development and validation of small and mid-size peptides to proteins, fusion proteins and monoclonal antibodies. The development of LCMS assays is followed by method validation and sample analysis consistent with global regulatory requirements and governed by SOPs.

Speaker:
Barry Jones, Ph.D., Associate Director, LCMS Biologics and Biomarkers