Immunogenicity Assays

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The evaluation of a drug candidate’s developability is a pivotal stage in the drug development process. Therapeutic antibodies and proteins can induce an immune response. Immunogenicity risk assessment is therefore a crucial aspect of biopharmaceutical drug development. Abzena’s experts offer immunogenicity assays, that help you better understand your drug.

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Although the potential for immunogenicity of therapeutic antibodies and proteins has been significantly reduced through the application of protein engineering technologies, clinical data shows that many biopharmaceuticals still induce an immune response in patients. Immunogenicity therefore remains a concern for companies developing new products and for the regulatory agencies asked to approve their use.

Our next-generation EpiScreen® 2.0 platform is Abzena’s innovative answer to these challenges. We utilize flow cytometry technology for precise, multi-dimensional immunogenicity assays. We provide a comprehensive suite of bioassays that predict and evaluate potential risks of preclinical immunogenicity in protein, antibody, and gene therapy therapeutics.

Smarter immunogenicity testing

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.

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Discover EpiScreen® 2.0

EpiScreen® 2.0 – Ex vivo assessment of immunogenicity

EpiScreen® 2.0 encompasses a package of assays that allow an accurate and sensitive way to assess the potential immunogenicity of proteins and antibodies ex vivo using a variety of methods such as measuring CD4+ T cell responses, the primary drivers of memory-based immunogenicity or evaluating MHC Class II peptide presentation.

EpiScreen® 2.0 Time Course T Cell Assay

The new EpiScreen® 2.0 time course T cell assay is used to assess the potential immunogenicity of therapeutic antibodies and other proteins before they reach the clinic. It is sensitive, specific, data-rich, MoA reflective, customizable and repeatable.

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EpiScreen® 2.0 DC:T Cell Assay

The new EpiScreen® 2.0 DC:T cell assay is used to assess the potential immunogenicity of therapeutic antibodies or other proteins that directly modulate CD4+ T cell activation.

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EpiScreen® 2.0 Cytokine Screen™

EpiScreen® 2.0 Cytokine Screen™ evaluates the potential of therapeutic proteins to activate innate and adaptive immune responses resulting in rapid and excessive cytokine release, which can produce significant toxicity. Abzena have developed an enhanced in vitro assay, Cytokine Screen™, to evaluate the risk of biopharmaceutical products causing cytokine release syndrome prior to clinical trials. Available as whole blood to assess innate responses or PBMC format to study adaptive responses with standard or bespoke cytokine panels.

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EpiScreen® 2.0 T Cell Epitope Mapping

EpiScreen® 2.0 T cell epitope mapping identifies the precise number and location of T cell epitopes within an antibody or protein. These can then be eliminated by generating humanized antibodies or deimmunized proteins.

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EpiScreen® 2.0 MAPPs

EpiScreen® 2.0 MAPPs detects and sequences naturally processed and presented peptides in the context of MHC Class II utilizing highly powerful mass spectrometry.

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TCED™ and iTope-AI – A powerful tool for in silico immunogenicity assay

iTope-AI and T Cell Epitope Database (TCED™) are in silico tools to rapidly screen antibodies and proteins for potential immunogenicity. Combined, they provide a more accurate prediction of T cell epitopes than other in silico technologies that rely on MHC class II binding analysis alone.

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Custom Immunology Assays

Abzena brings together expertise in immunology with the technology required to perform bespoke immunology assays. Our large bank of characterized PBMC, regulated by the human tissue authority, supplies fresh whole blood, buffy coats, apheresis cones and leukopaks as well as a large range of cell lines that can be used for collaborative studies. Typical read-outs include immunophenotyping, activation markers, cytotoxicity, live cell imaging and cytokine analysis by Luminex and FluoroSpot.

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