Local toxicity & Formulation safety

Julie Magerman¹, Katarzyna Polak², Ornella Binazon¹, Michael Pastore², Alexandra Ochando², Judith Baumeister^1
1argenx, ²Genoskin

Formulation safety testing still relies heavily on in vivo studies due to limited validated in vitro alternatives. Genoskin’s HypoSkin^® biostabilized ex vivo human skin enables multi-parametric local tolerance assessment after subcutaneous injection. In a validation study, the model detected toxic control formulations with strong in vitro–in vivo correlation, using robust macroscopic imaging and histopathology endpoints for standardized scoring.

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