Intradermal device testing

A collaboration study with Pharma Latch

Replacing animal testing in local tolerance assessment of an injection device: Human ex vivo HypoSkin® model as a New Approach Methodology (NAM)

Jérémy Argenty1, Clémence Letzelter1, Catherine Marques1, Sophie Abadie1, Alexia Sanchez1, Claire Gendrin1, Alexandra Ochando1, Adam Rock2, Ronan Byrne2, Pascal Descargues1, Nicky Bertollo2
1Genoskin, 2Pharma Latch

HypoSkin® is an ex vivo human skin NAM that preserves native immune cells and tissue architecture for local tolerance testing. Using a customized workflow, we compared an innovative fixed-depth intradermal device with a 30G syringe and reference device. All injections were well tolerated, with preserved histology and only mild, physiological cytokine responses, including comparable vaccine-induced activation.

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