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 and Nicky Bertollo2
1Genoskin, 2Pharma Latch
Advancing intradermal device safety testing with human skin-based NAMs
Evaluating the safety and local tolerance of intradermal injection devices remains challenging, highlighting the need for human-relevant alternatives to animal testing that capture native skin responses.
Genoskin’s HypoSkin® is an immunocompetent human ex vivo skin model that preserves the epidermis, dermis, hypodermis, and resident immune cells, enabling the evaluation of injectable therapies and medical devices under controlled conditions.
Presented at SOT 2026, this study, conducted in collaboration with Pharma Latch, compared an innovative fixed-depth intradermal injection device with a conventional 30G syringe and a reference device. Results demonstrated preserved tissue integrity, mild inflammatory responses, and comparable vaccine-induced immune activation across injection methods.
HypoSkin® provides a human-relevant platform to assess injection device tolerability, characterize local tissue responses, and support preclinical medical device and vaccine development while helping reduce reliance on animal testing.
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