Is Your Biotherapeutic Immunogenic? How to Use Immunoassays to Get the Right Answer

Life Sciences, Pharmaceutical, Drug Discovery & Development, Drug Safety, Biosimilars, Preclinical,
  • Wednesday, October 03, 2018

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.


Dr. Bruno Paquin, VP Business Development, Immuni T

Dr. Paquin has worked in the biotech industry for over 18 years in R&D and business development and has been working with Immuni T as VP Business Development since April 2011. Prior to Immuni T, Dr. Paquin was Executive Director, Business Development at Genizon Biosciences where he was instrumental to the progress of Genizon’s discovery programs as well as heading the business development activities. Dr. Paquin obtained his Ph.D. in biochemistry from the Université de Montréal and was an NSERC and FRSQ post-doctoral fellow at University at Albany – SUNY.

Message Presenter

Dr. Mario Filion, EVP and CSO, Alethia Biotherapeutics

Dr. Filion was involved in the creation of Alethia Biotherapeutics in 2002. In his current position, he oversees Alethia’s R&D operations. Prior to Alethia, he acted as President of the Clinical Genomics Unit at SignalGene. Prior to SignalGene, Dr. Filion served as Director, Biotechnology at T2C2/Bio, a leading venture capital fund in Montréal. Mario holds a Ph.D. degree in molecular biology from Université de Montréal and was an NSERC and FRSQ post-doctoral fellow at McGill University.

Message Presenter

Who Should Attend?

  • Biotherapeutics Developers
  • Biosimilar Developers
  • Biotech and Biopharma R&D Scientists (CSO, Scientific Directors, Principal Scientists, etc.)
  • Regulatory Affairs Scientists in Immunogenicity

What You Will Learn

Join this webinar to learn how:

  • Immunogenicity of biotherapeutics can impact both the efficacy and the safety of the drug
  • Biotherapeutics can provoke morphological changes, proliferation alterations and functional phenotype switching of immune cells that can be detected using Immuni T’s tools and assays
  • Assessment of immunogenicity and allergenicity is pivotal to the development and use of biotherapeutics
  • Ex vivo immunogenicity assessment assays and appropriate data interpretation are useful and physiologically relevant to evaluate the potential risk associated with immunogenicity of biotherapeutics
  • Better knowledge of the immune characteristics of the drug at an early stage of development will save time and money and will allow better preclinical and clinical design
  • To achieve better and safer R&D effort at all phases of drug development

This webinar will educate the participant on the effects of immunogenicity and ex vivo immunogenicity assays to measure immune responses.

Xtalks Partner

Immuni T

Immuni T is a CRO founded in 2005 providing high-quality services in immunology with a core expertise in flow cytometry, cell culture and ligand binding. From customized cell-based assays to GLP-compliant bioanalysis, we support all phases of biotherapeutics and vaccine development. Immuni T performs cytotoxicity (e.g. ADCC, CDC) and other cell-based assays (including whole-blood assays) with a specialty at using primary cells; human ex vivo immunogenicity prediction/comparison assays for new biotherapeutics and biosimilars as well as immunogenicity tests (ADA and nAb) for biotherapeutics in clinical development; ligand-binding assays for the quantification/detection of peptides, proteins or nucleic acids (ELISA and MSD platforms); immuno assays based on FACS analysis for determination of cell function and molecules quantification; multiplex analysis on Luminex, complement activation/inhibition assays as well as customization, development and validation of assays for pre-clinical and clinical sample analysis in a GLP-compliant environment.

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