Monoclonal Antibodies

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Hundreds of sponsors with mAb therapeutics trust BioAgilytix for their pharmacokinetic (PK), immunogenicity, biomarker, and CMC bioanalytical needs, whether for assay development or sample testing.

Rapidly obtain the quality data you need to progress your leading therapeutic candidates by relying on our advanced platforms and unrivaled scientific expertise.

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Services

  • 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)

PRESS RELEASE

Streamline bioanalytical testing with integrated services. 

High-quality custom antibody reagents in support of timely bioanalytical assay creation and testing development

Simplify the bioanalytical testing experience by working with a single provider for swift access to high-quality, custom antibody reagents suitable across testing applications. This is possible through the integration of BBI’s proven, efficient mono- and polyclonal custom antibody reagent development services with BioAgilytix’s bioanalytical renowned testing solutions.

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Our Monoclonal Antibody Services Include

Ready to Start Your Project?

Our scientists are available to discuss your project and how our bioanalytical CRO can help you streamline the drug development process.