Safety Assays

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Although the body’s immune system functions effectively to restore homeostasis after a biological or physical insult, the protective mechanisms can become detrimental when over activated. This is often seen when new pharmaceuticals or medical devices intended to promote healing are introduced in to the body but cause unintended over activation of the immune system. Increased expression of pro-inflammatory cytokines or excessive cellular proliferation is often seen in the activated immune response. The importance of assessing the inflammatory response in humans was emphasized after the failure of animal models to predict the resulting cytokine release in human subjects in the TGN1412 phase I clinical trial resulting in a life threatening “cytokine storm” in the six trial subjects.

Xeno Diagnostics offers several assays to test immune cell function in an in-vitro assay using donor human PBMCs with client test articles.

  • Cytokine expression assaysanalyze cytokine expression
    • Cytokine levels are assessed after a test article is presented to PBMCs. Both pro-inflammatory cytokines (such as IFN-γ, TNF-α, IL-2, IL-6) and anti-inflammatory cytokines (TGF-β, IL-10) are measured in the media recovered after co-incubation of the PBMCs and test articles.
  • Proliferation assaysmeasure proliferative response
    • Proliferation is often caused by antigenic stimulation and can be measured after co-culture with PBMCs and the test article. Both increased or decreased proliferative responses can be measured, including analysis in T-cell subsets.

Xeno Diagnostics is a CLIA certified high complexity lab and adheres to GLP and GCLP standards. We have had years of experience helping clients navigate the regulatory landscape and produce high-quality assays, documentation, and reporting to fit the regulatory requirements for each stage of product development.