TORONTO, September 17, 2018 – Join Dr. Bruno Paquin, Vice President of Business Development at Immuni T and Dr. Mario Filion, Executive Vice President and CSO of Alethia Biotherapeutics on Wednesday, Oct. 3, 2018 at 1 p.m. EDT (10 a.m. PDT) for an insightful and interactive presentation.
Biotherapeutics are a class of large medicinal products that are being increasingly used for various medical applications including vaccination, therapeutic drug delivery systems and the treatment of human diseases. Biotherapeutics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, they can inappropriately activate the immune system. This potential biotherapeutics-mediated immunogenicity must be assessed as early as possible during drug development since it can be the cause of serious events such as autoimmunity, inflammation, anti-drug antibodies (ADAs) production, hypersensitivity reactions (allergenicity) or cytokine storm syndrome. Moreover, since biotherapeutics are produced using biological means, the development of biosimilars must include comparative immunogenicity and biological assay testings.
Immuni T has developed numerous tools and assays for assessing the immunogenicity and functional activity of biotherapeutics, vaccines and biosimilars that are useful from early development to late clinical phase. The presentation will focus on an ex vivo assay performed in primary human or animal peripheral blood mononuclear cells (PBMCs) or rodent splenocytes, with examples on how to use and interpret the data for early safety screening as well as in support for biosimilarity in regulatory data package submissions. Concrete examples will be shown using various biological outcomes that can be measured at different stages of immune cell activation, including cytokine secretion, expression of cellular activation markers and proliferation.
T and B lymphocyte subsets, NK cells, monocytes, macrophages, dendritic cells and cytokines are all involved in a complex manner to determine the intensity, orientation, and duration of the immune response through the expression of cellular and molecular markers. A number of immunoassays based on ligand binding, flow cytometry, and cellular assay platforms were developed and implemented at Immuni T to support better and safer drug development. Therefore, ex vivo immunogenicity assays are pivotal to evaluate the risk of immunogenicity and to gain awareness as early as in the discovery phase.
In conclusion, immunosafety assays of biotherapeutics to assess their propensity to elicit undesirable immune responses are an essential part of their development. Overall, the possibility of shaping immune reactivity with biotherapeutics to control their respective risk of immunogenicity or allergenicity would be extremely beneficial for the optimization of safety and efficacy.
For more information or to register for this event visit: Is Your Biotherapeutic Immunogenic? How to Use Immunoassays to Get the Right Answer.
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