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Functional Activity &
Immunogenicity

Reliable assays 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.

Abzena’s approach focuses on developing phase-appropriate assays 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:
    • EpiscreenTM time course assay
    • EpiscreenTM DC:T cell assay
  • Identification of immunogenic sequence “hot spots” using:
    • In silico assessment by iTope-AI
    • MHC Class II associated peptide proteomics (MAPPs)
    • EpiscreenTM T cell epitope mapping
  • Safety assessment of proteins with potential to induce cytokine storm
    • Cytokine Release Assay

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

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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.

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