On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
Antibody drug conjugates (ADCs) continue to show significant therapeutic promise, and BioAgilytix is here to help support their development for life-changing outcomes. We have been supporting customers at the leading edge with expert antibody drug conjugate testing services, and will apply that first-hand expertise to your distinct project requirements.
ADC development work specialized and technically challenging, combining both chemistry and biotechnology innovations. The heterogeneous mixture of monoclonal antibody and small molecule payload requires studies that characterize the clinical pharmacology of both antibody-drug conjugate components. Minimal regulatory parameters have been formalized around this emerging science, also creating challenges. Because of this complexity, your partner in the development of antibody drug conjugates must be well-versed in conjugation strategies, and understand the critical factors that should be considered to select the appropriate bioanalytical techniques.
BioAgilytix’s scientific team has been supporting customers at the leading edge of antibody drug conjugate development, and will apply that first-hand expertise to your distinct project requirements. Our scientists understand the complexity of ADCs and the development of assays required to measure free total drug conjugates and naked molecules for PK analysis. In fact, we have supported immunogenicity and PK studies for antibody drug conjugates in a variety of species including rodents, humans, and nonhuman primates.
BioAgilytix provides ligand binding and LC/MS assay development and validation on multiple platforms in support of antibody-drug conjugate projects. BioAgilytix has experience developing assays for immunogenicity across the bioanalytical lifecycle requiring high drug tolerance levels. Our state-of-the-art bioanalytical laboratory also allows for development and analysis of potency assays, as well as bioanalytical testing of antibody-drug conjugates, using the variety of bioanalytical platforms listed below.
BioAgilytix has become the partner of choice for organizations seeking to advance their biologics strategy, and take the lead in developing next-generation antibody drug conjugates for more targeted and effective therapeutic treatments.
Our experts understand the complexities that must be addressed in immunogenicity studies, PK analysis, and NAb assays related to ADCs, and will help you determine the optimal analytical equipment platform to yield high-quality data results. We offer these services under GLP, GMP, and GCP to meet your regulatory requirements.
Let us help you remove the roadblocks of complexity on your path to developing safe, effective antibody drug conjugates.