ISR Platform^®: Toxicity services for injectable therapeutics & Drug Delivery Systems

Assessing local toxicity, injection site reactions (ISRs), and tissue tolerance remains a major challenge in injectable drug and medical device development. Conventional preclinical models may not fully capture human-specific inflammatory responses, formulation-related effects, or interactions between delivery systems and surrounding tissue.
In this application note, we explore how Genoskin’s ISR Platform^®, powered by the HypoSkin^® ex vivo human skin model, supports human-relevant non-clinical toxicity assessment. By preserving all three skin layers and resident immune cells, HypoSkin^® enables the investigation of intradermal and subcutaneous injections under controlled experimental conditions.

Through three case studies, the application note illustrates how the ISR Platform^® can be used to:

• Assess formulation and excipient tolerance, including inflammatory and transcriptomic responses following polyethylene glycol (PEG) injection.
• Investigate monoclonal antibody precipitation and aggregate formation within subcutaneous tissue.
• Evaluate medical device biocompatibility and local tolerance following subcutaneous implantation.
• Characterize immune activation and tissue responses to sustained therapeutic protein delivery using cytokine profiling and gene expression analysis.

Download the application note to explore the experimental findings and discover how human skin-based testing can support toxicity assessment, formulation optimization, and drug delivery system development.