Bioconjugate & ADC Analytical Method Development & Bioassays - Abzena

Bioconjugate & ADC Bioassays & Analytical Method Development

Reliable bioassays and analytical method development for bioconjugates and antibody-drug conjugates (ADCs).

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Early, informed decision-making.

Bioconjugates and antibody-drug conjugates (ADCs) are complicated molecules combining biopharmaceutical and chemical properties that can be challenging to analyze and characterize. Whether you need to answer a stand-alone question or your bioconjugation program requires complementary bioassays or analytical method development, Abzena can provide you with the comprehensive, rapid analytical data to move forwards.

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The approach that we take to the challenge focuses on giving you insight to make informed decisions during your drug development journey.

Our experts develop phase-appropriate bioassays for assessment of potency, efficacy and safety, giving you the benefit of our experience across a diverse range of modalities.

In addition, we develop and comprehensively document the phase appropriate analytical methods necessary to produce high-quality, well-characterized material in combination with the rapid data needed to support successful IND and marketing applications.

Extensive panel of both target and effector cells

To help understand your molecule in detail, we have an extensive panel of both target and effector cells together with a substantial in-house PBMC cell bank.

Complementing this is a broad choice of bioassay platforms, including:

  • Luminescence, fluorescence, absorbance plate-based assays
  • BiacoreTM
  • Flow cytometry
  • Incucyte® live cell imaging (and other microscopy techniques)
  • Cytokine analysis (Luminex®, FluoroSpot)
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GMP Cell-Based Potency Assessments for Bioconjugates

GMP cell-based potency testing quantitively measures the biological activity of a bioconjugate drug. For Antibody-drug conjugates (ADCs), these critical assessments measure the cytotoxicity of the payload for both GMP product release and long-term stability testing. These important assays enable us to provide our customers with reliable data on their drug’s potency, which is essential for regulatory submissions.  

By offering GMP cell-based potency assays alongside our robust suite of bioassay capabilities including developability, characterization, mechanism of action (MOA) studies, and immunogenicity, we can provide our customers with a more comprehensive, streamlined, and cost-effective way to access critical data even faster.  Ultimately, allowing them to make data-driven decisions even sooner in their development journey.

LabZient™ - Abzena

Introducing LabZient™, our analytical platform that expedites the path to IND

Developed by our scientific experts to increase our biopharmaceuticals customers’ chances of clinical success and provide rapid data, LabZient™ is our next-generation analytical solution. To learn more, or access our latest LabZient™ info sheet, click the button below.

Discover LabZient™

Antibody Discovery

Our comprehensive bioassay solutions include both established assays and custom assay development matched to your individual program needs. Our bioassay services include the following:

Target validation

  • In vitro gene/protein expression
  • Functional analysis – Assessment of signalling pathways and cell health
  • Biomarker profiling – Surface markers, cytokine production

Hit-to-lead screening

  • Target binding and affinity – ELISA, BiacoreTM, flow cytometry
  • Functional activity – Reporter assays and primary cell assays

Antibody Design & Development

Specificity & tissue profiling

  • On-target binding to cell lines or primary disease tissue
  • Off-target binding to primary immune cells or normal tissue
  • Polyspecificity assessment

Mode of action

  • Ligand binding and competition
  • Internalisation and trafficking
  • Viability assessment – 2D/3D viability assay, cell cycle arrest, apoptosis, bystander effect, co-culture cell killing
  • Gene and protein knockdown
  • Fc effector function – ADCC, ADCP & CDC
  • MLR & superantigen proliferation and cytokine analysis
  • PK & PD assessment

Immunogenicity & Safety assessment

  • Immunogenicity risk assessment of proteins using:
    • Episcreen® 2.0 time course assay
    • Episcreen® 2.0 DC:T cell assay
  • Identification of immunogenic sequence “hot spots” using:
    • In silico assessment by iTope-AI
    • MHC Class II associated peptide proteomics (MAPPs)
    • Episcreen® 2.0 T cell epitope mapping
  • Safety assessment of proteins with potential to induce cytokine storm
    • Cytokine Release Assay

Access is latest info sheet on our newly enhanced EpiScreen 2.0 platform to learn more.

Biologics Manufacturing – Potency & Batch Release

Manufacturing – Potency & Batch release

  • Development of ELISA or cell-based binding assays
  • Development of MoA-reflective potency assays
  • Assay pre-qualification and transfer
“I had the pleasure of working with Abzena’s Cambridge, UK team on a variety of in vitro pharmacology projects, ranging from cell-based assays to Biacore kinetic analysis. I found the team to be professional, reliable, and excellent partners. Given the virtual nature of the company I work for, we rely on strong partnerships in order to produce quality data to allow us to make strategic program decisions. The Abzena team was instrumental in providing timely, high-quality data that impacted our decision-making. I would highly recommend this team for all your preclinical pharmacology needs.”

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Let's move medicine forward.

We adapt our approach to shorten lead times and develop risk mitigations strategies to ensure your overall success in delivering vital medicines to patients.

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