Antibody Drug Conjugate Testing Services – Accurate and Reliable Results
Antibody-Drug Conjugate Testing (ADC)
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.
Find Answers to your ADC Questions
Antibody drug conjugates provide a compelling combination of high specificity and therapeutic efficacy by targeting antigens that are differentially overexpressed in tumor cells, while minimizing exposure of healthy tissue. This innovative therapeutic application represents significant opportunity for the pharmaceutical and biotechnology industries, but it is also technically challenging. ADCs are essentially ‘empowered antibodies’ designed to harness the targeting ability of monoclonal antibodies (mAbs) by linking them to cell-killing agents. The efficacy of antibody drug conjugates is achieved by covalently linking monoclonal antibodies that recognize a specific tumor-associated antigen to a cytotoxic agent via a stable linker. The agent is designed to induce cell death only after it is internalized and released by the mAb into a specific cancer cell. Compared to standard chemotherapies and cancer biologics, antibody drug conjugates limit systemic exposure and increase drug tolerability – delivering lethal payloads directly to targeted tumor cells, while leaving healthy tissue untouched.
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.
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 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.
2014 Shankar, Kromminga Et Al. Paper
Assessment And Reporting Of The Clinical Immunogenicity Of Therapeutic Proteins And Peptides
For more information emphasizing associations of ADA development with pharmacokinetics, efficacy, and safety that are necessary to assess the clinical relevance of immunogenicity.
Our ADC-Related Services Include
Immunogenicity risk assessment is critical to the development of most therapeutic modalities. It can affect both safety and efficacy, ranging from no evidence of clinical…