EpiScreen™ Time Course T Cell Assay

EpiScreen™ is an accurate and sensitive way to assess the potential immunogenicity of proteins and antibodies ex vivo by measuring CD4+ T cell responses, the primary drivers of memory-based immunogenicity. The EpiScreen™ time course T cell assay is used extensively across the industry as a standard for preclinical immunogenicity testing.

The assay provides an accurate and sensitive way to assess the overall immunogenicity of protein therapeutics during early lead selection or during manufacturing. For each study a donor cohort is selected to best represent the distribution of HLA-allotypes in the human population.

By measuring CD4+ T cell responses ex vivo, the assay assesses the strength and kinetics of an individual’s T cell response to a protein therapeutic, thereby giving an indication of an immunogenic response against the protein.

The assay can facilitate lead selection based on the immunogenicity of whole proteins including mAbs and other human and non-human protein therapeutics. It can also assess the immunogenicity following antibody humanisation and protein deimmunisation.

EpiScreen™ has correlated with reported anti-drug antibody responses in the clinic

A correlation has been shown between the frequency (%) of CD4+ T cell responses in the EpiScreen™ assay and the frequency of patients that develop ADA for a range of therapeutic proteins.

Correlation Graph

 

 

Left: An analysis of 16 clinical-stage biologics where the frequency of donor responses by EpiScreen™ analysis demonstrates a high correlation with the average frequency of patients developing anti-drug antibodies reported in clinical studies (Baker et al., 2007 and Barker et al., 2010)

About the assay

Assays are performed using bulk cultures of peripheral blood mononuclear cells (PBMCs), typically from 50 individual donors, with a distribution of HLA-DR allotypes (coverage and frequency) representing the human population of interest.
T cell proliferation and IL-2 secretion, both markers of T cell activation, are measured using 3H-thymidine incorporation and ELISpot, respectively. Strong correlation between these markers enables the detection of CD4+ effector T cell activation and discriminates between T cell effector and regulatory responses.

Working with Abzena

Abzena’s services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results. Time course T cell assays are usually completed in 8-10 weeks depending on the number of proteins run in parallel.

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