Antibody-Drug Conjugate Analysis
Antibody-drug conjugates are among the most dynamic targeted cancer therapies, designed to deliver highly potent cytotoxic payloads specifically to tumor cells while limiting effects on healthy tissue. This requires a precise understanding of antibody structure, payload conjugation, target-binding properties as well as plasma stability.
At Biofidus, we offer end-to-end antibody-drug conjugate (ADC) analysis and characterization services covering both structural and functional characterization to build a robust, regulator-ready data package for your ADC project.
Our analytical portfolio includes in-depth protein primary structure analysis, post-translational modification profiling, determination of drug-to-antibody ratio (DAR) and DAR distribution, assessment of conjugation sites, level of aggregation and free payload, as well as stability and forced-degradation studies to evaluate linker and payload stability under relevant conditions.
Functionally, we characterize your lead ADC molecules using customized cell-based potency assays, target-binding and kinetics by surface plasmon resonance (SPR) or related technologies, and, where needed, assays that probe internalization and mechanism of action.
Our vast experience and deep knowledge in ADC analytics allow us to guide you through the variety of available methods and to define the optimal analytical strategy for your antibody-drug conjugate.
In accordance with your needs, we adapt and, if required, qualify our platform methods according to ICH guidelines, tailoring them to your drug substance (DS), its formulation matrix and your specific analytical questions.
Get in contact with us to quickly identify the optimal setup for your ADC analytical challenge and to speak directly from expert to expert.
