【Case Study】New Approach Methods NAMs

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2D vs 3D hepatocyte model for acetaminophen-induced toxicity

A 2D HepG2 culture and 3D HepG2 spheroid system can be used to evaluate acetaminophen-induced toxicity with image-based analysis and viability readouts, illustrating how 3D systems can support longer-term, repetitive exposure designs.

Cytokine Release Assay (CRA) for immune activation risk

Medicilon supports CRA using fresh human PBMCs (multiple donors) with solid- and liquid-phase formats, customizable incubation conditions, and multi-cytokine panels (e.g., IL-2, IL-6, IL-10, IFN-γ, TNF-α, IL-1β, IL-4, IL-12p70; optional expansion to include IL-8, IL-13) to assess immune activation risk.

Platelet viability / activation assays

Fresh human platelets can be used for platelet toxicity (e.g., CTG readout) and activation assessment by flow cytometry (e.g., CD62P), supporting risk assessment for platelet liabilities.

Multi-omics off-target assessment

Transcriptomics (RNA-seq) can be used to evaluate potential off-target effects of oligonucleotides in cell systems, and proteomics workflows can support off-target profiling for modalities such as PROTACs under different exposure conditions.

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