In vitro Immunogenicity and Functional Testing of Nanoparticles, mRNA, and Biologics


In a recent presentation during Oxford Global’s Biologics UK conference, Sofie Pattijn, site leader for ImmunXperts, a Q2 Solutions company, shared how in vitro bioassays provide a view of innate and early immune response.   Sofie highlighted several assays as examples to discuss the versatility and customization available to understand the immunologic mechanism of the therapeutic, such as a biologic.

Three categories of in vitro bioassays, which function as early immunogenicity tools, featured during this conference included:

  • Early / Innate Assays
  • T-cell Assays
  • MAPPS assays

These categories are unique as they each focus on a different sub-class of immune cells.  All are important to obtain a view of the therapeutic impact on cellular pathways.  The report and data generated from these groups of assays aids sponsors through:

  • Interpretation of the cells and measurement of the upregulation of certain test markers and cytokines
  • Challenging the immunogenicity potential of the test molecule
  • Identify which part of the molecule induces an immune response

Sofie illustrates the range of assays ImmunXperts designed to address both wanted and unwanted immunogenicity.  Additionally, the presentation spotlights the customization of assays are through the utilization of technology, such as flow cytometry and Luminex.  Learn more about how essential in vitro bioassays are in gaining early insight.


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