Monoclonal Antibodies

The design and implementation of bioanalytical testing strategies for monoclonal antibody therapeutics is one of BioAgilytix’s key areas of focus. Our comprehensive expertise covers a range of therapeutic areas, matrices, and analytical techniques.

Bioanalytical Support for Monoclonal Antibodies

Monoclonal antibodies (mAbs) 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 disease, and infectious diseases. Learn more about our support for mabs programs which includes:

Strategies for Successful Assay Design

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)

Featured Case Study: Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization 

Learn more about how BioAgilytix’s scientists leveraged our extensive expertise in bioanalysis to achieve the necessary levels of drug tolerance and sensitivity while minimizing target interference in an ADA assay.