Immunogenicity Profiling

Immunogenicity Profiling

Immunogenicity risk limitation is a critical consideration during the development of biologic drugs.

Accuro Biologics Immunogenicity Profiling services exploit software and database tools together with ex vivo human T cell assays to test whole proteins, synthetic peptides or peptidomimetic structures for their ability to evoke T cell activation events in human cells.

Epitope Mapping

Applications of the technology include the identification of human helper T cell epitopes in candidate biopharmaceuticals (epitope mapping). Such identification can provide the critical information required for engineering alternative variants of the protein with a more favourable immunogenicity risk profile (e.g. epitope depletion engineering).

Immunogenicity Profiling

Relative Immunogenicity Analysis

Immunogenicity assays may be used to filter candidates from a library of related candidates (e.g. fully-human antibodies) or identify helper T cell epitopes for vaccine applications.

Software and database tools are used to support our analysis. We focus on the critical interaction between the MHC class II binding groove and the peptide epitope presented to the T cell receptor. The core of our service is provided by the availability of an extensive tissue bank of HLA typed peripheral blood mononuclear cells prepared from samples from healthy donors.

Human T cell assays are conducted using sets of donor PBMCs specifically selected to ensure both maximal population coverage of HLA types and statistical validity in data interpretation.

We score T cell activation events based on measurement of both CD4+ T cell proliferation and antigen induced cytokine profiling. The T cell activation assays may be conducted in a number of different technical formats depending on the study purpose and the nature of the molecule of interest.

General Project Features:

  • Ultra sensitive T cell proliferation detection through tritiated thymidine or non-radioactive read-outs.
  • Cytokine profiling - multiple choice of cytokines.
  • Studies are conducted using multiple donor samples in parallel.
  • Modular and affordable cost structure based on sponsor choice of measurement options and size of study.
  • Projects typically conducted in 3 - 4 month timescale.
  • Sponsor owns all data and receives full project report and documentation.

 

See also: Antibody Engineering | Protein Engineering | Cell Line Development

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