Bioconjugate & ADC Analytical Method Development & Bioassays - Abzena

Bioconjugate Bioassays & Analytical Method Development

Reliable bioassays and analytical method development for bioconjugates including ADCs, AOCs and RDCs.

Bioassays Info Sheet Early Phase Bioassays

Leverage our analytical expertise across bioconjugate and ADC discovery, development and manufacturing.

Bioconjugates and antibody-drug conjugates (ADCs) combine complex biopharmaceutical and chemical properties that make characterization challenging. Abzena provides expert analytical services for bioconjugates, delivering the rapid, high-quality data needed to advance your development program with confidence.

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Whether supporting a specific analytical question or an integrated bioconjugation project, our teams design and validate phase-appropriate bioassays and analytical methods to assess potency, efficacy, and safety.

Our specialists have extensive experience in bioconjugates analytical development, creating reliable methods and detailed documentation to support IND submissions and marketing applications. This ensures every bioconjugation program is backed by reproducible, regulatory-ready data.

Comprehensive Cell & Bioassay Platforms for Bioconjugate Analysis

To support detailed molecular understanding, Abzena maintains an extensive panel of both target and effector cells, alongside a large in-house PBMC cell bank. This infrastructure enables accurate assessment of complex bioconjugates and bioconjugation products.

Our analytical scientists use a wide range of bioassay and analytical platforms for bioconjugates, including:

  • Luminescence, fluorescence, and absorbance plate-based assays
  • Biacore™ for binding kinetics
  • Flow cytometry
  • Incucyte® live-cell imaging and other microscopy techniques
  • Cytokine analysis via Luminex® and FluoroSpot

This combination of technologies allows precise measurement of potency, functionality, and biological response across multiple bioconjugates and ADC modalities.

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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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Bioconjugate Bioassays & Analytical Method Development FAQs

What are bioconjugates?

Bioconjugates are hybrid molecules linking biological and chemical components. They include antibody-drug conjugates (ADCs) and antibody-oligonucleotide conjugates that can be used in highly targeted therapies.

What is bioconjugates analytical development?

Bioconjugates analytical development involves designing and validating analytical methods to characterize bioconjugates for identity, purity, potency, and stability.

What analytical services for bioconjugates does Abzena offer?

Abzena provides comprehensive analytical services for bioconjugates, including LC-MS, bioassays, cytokine analysis, and binding studies using Biacore™ and flow cytometry.

Why is bioassay testing important in bioconjugation?

Bioassay testing confirms the biological activity and mechanism of action of bioconjugates. It ensures consistent potency and supports regulatory submissions.

How does Abzena support bioconjugation programs?

Abzena delivers end-to-end analytical and bioassay support for bioconjugation, from early characterization through IND and GMP manufacturing stages.

Integrated Cell Line Development - Abzena

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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