Proimmune has launched the DC T Cell Proliferation Assays based on its CFSE detection platform to assess the immunogenicity of whole proteins.
This highly sensitive, versatile assay determines whether candidate proteins induce helper CD4+ T cell proliferation that may lead to anti-drug antibody responses or other unwanted immunogenicity.
The novel assay is said to significantly improve data quality over traditional radioactive assay methods.
It also offers the possibility for phenotyping T cell responses further, for example, to understand more clearly the actual observed phenomena during clinical-stage development.
In the assay, monocyte-derived dendritic cells (DCs), obtained from Proimmune's high-resolution tissue-typed bank of healthy PBMC donor samples, are loaded with the candidate protein.
These loaded and activated DCs process and present the candidate protein to CFSE-labelled PBMCs.
Where the candidate protein has immunogenic properties, CD4+ T cell proliferation occurs.
This is detected through a CFSE-based flow cytometric assay to accurately determine the percentage of proliferating CD4+ T cells.
Antigen presentation by dendritic cells avoids assay interference due to direct modulation of target T cells by the candidate drug and allows the relative antigenicity of different leads to be compared directly.
The assay allows for an overall comparison of the T-cell-driven antigenicity of any number of drug candidates at a preclinical stage.
It can also be used for assessing the impact on antigenicity of factors other than protein sequence.
Such differences may include a comparison of biosimilars, protein modifications, degradation products, chemical entities given in combination therapies, and other parameters related to manufacturing processes, excipients, drug formulation and stability.
