Local Toxicity and Formulation Safety: An argenx Collaboration Study
Evaluating the local safety of injectable formulations remains challenging, as conventional preclinical methods may not fully predict human tissue responses. Human-relevant New Approach Methodologies (NAMs) offer promising alternatives to support formulation development and safety assessment.
Genoskin’s HypoSkin® is an immunocompetent human ex vivo skin model preserving the epidermis, dermis, and hypodermis, enabling the evaluation of local tissue responses following subcutaneous injection.
Presented at SOT 2026, this study, conducted in collaboration with argenx, demonstrated the ability of HypoSkin® to detect toxic control formulations, with strong agreement between ex vivo and in vivo findings. Macroscopic imaging and histopathological analysis enabled standardized assessment of local tissue damage.
HypoSkin® provides a human-relevant platform to evaluate injection site toxicity, compare formulation tolerability, and support preclinical safety decisions while helping reduce reliance on animal testing.
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