Cell Line Development (CLD)Bioassays & ImmunogenicityAnalytical Method DevelopmentFormulation DevelopmentProcess Development and Manufacturing

Bioassays & Immunogenicity

Reliable bioassays to characterize your product.

Your program will benefit from Abzena’s wealth of experience and expertise across a diverse range of modalities including conjugates, multi-specifics, fusions, fragments, agonist, and antagonist activities.

When it comes time to evaluate the immunogenic risk of your biopharmaceutical program, our newly enhanced EpiScreen 2.0 platform offers a comprehensive suite of assays that can predict and evaluate potential risks of preclinical immunogenicity in protein, antibody, and gene therapy therapeutics

Our unique, next-generation tool delivers a more advanced set of immune response measurements with the required sensitivity, plus detailed information on specificity and MoA to better inform the nature of immunogenicity risk and offers insights into how to mitigate this through protein engineering and formulationTo learn more, access the info sheet here.

Abzena’s approach focuses on developing phase-appropriate bioassays for assessment of potency, efficacy and safety, giving you tools to make effective decisions during your drug development journey.

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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 assay platforms, including:

  • Luminescence, fluorescence, absorbance plate-based assays
  • BiacoreTM
  • Flow cytometry
  • Incucyte® live cell imaging (and other microscopy techniques)
  • Cytokine analysis (Luminex®, FluoroSpot)

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

 

Discovery

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

Design and Developability

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.

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

Microscopy

At Abzena, we leverage advanced microscopy techniques to deliver precise and detailed insights into your biopharmaceutical products. Our state-of-the-art imaging capabilities, including Incucyte® live cell imaging, enhance our real-time ability to analyze cellular behaviors, interactions, and responses. This high-resolution analysis is integral to our comprehensive bioassay services, supporting assessing functional activity, immunogenicity, and overall efficacy. Integrating these powerful imaging tools ensures a deeper understanding of your molecule’s performance, driving your drug development forward with confidence and clarity.

Hear what our customers have to say:

“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.”

Work with us

From bench to bedside, we are dedicated to ensuring quality excellence in everything we do.

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