Monoclonal Antibodies

• Support for mAb therapeutic preclinical and clinical development, from early-phase drug discovery to clinical testing utilizing LC/MS and ligand-binding assay (LBA) platforms
• Multiple endpoint sourcing with a single service provider for your pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity, biomarker, and CMC bioanalytical assay development, validation, and sample testing
• Extensive experience working with murine, chimeric, humanized, and fully human antibodies in animal and human studies across numerous indications

Monoclonal antibodies can fall into different structure-specific subcategories, including murine, chimeric, humanized, and fully human antibodies. BioAgilytix has extensive experience working with each of these antibody types in both animal and human studies in numerous therapeutic indications, including but not limited to cancers, autoimmune diseases, and infectious diseases. Our support for mAbs programs includes:

• Pharmacokinetics
• Pharmacodynamics
• Immunogenicity
• Biomarkers
• CMC Bioanalytical

Monoclonal antibodies are generally well-tolerated, however the high circulating levels of the antibody during sample collection can interfere with bioanalytical testing. Our scientific teams are experienced with proactively applying sample pretreatment options during assay development to improve drug tolerance, mitigating this issue. These include:

• Acid dissociation
• Solid-phase extraction with acid dissociation (SPEAD)
• Affinity capture elution (ACE)
• Biotin-drug extraction with acid dissociation (BEAD)
• Bead-extraction and heat-dissociation (BEHD)