ISR Platform Toxicity pilot study Local toxicity assessment in ex vivo human skin models

5 December 2025 By Genoskin Comments are Off

ISR Platform – Toxicity pilot study

Local toxicity assessment in ex vivo human skin models

Human-based pilot study for early local toxicity assessment

De-risk your injectable therapeutics with a New Approach Methodology

Genoskin

Experimental conditions

1 donor (n=3)
1 vehicle (negative control)
1 TA
1 positive control

Toxicity pilot study

Analysis

H&E staining
Multiplex cytokine analysis

Evaluate local toxicity using biostabilized human skin

Study overview

Genoskin

Objective of the study

Evaluating local toxicity and injection site reaction in human skin is essential to de-risk injectable therapeutics before moving to clinical stages. Genoskin’s HypoSkin® platform provides an ex vivo, immunocompetent human skin model that preserves native structure, innate immune components, and subcutaneous architecture – delivering human-relevant insights that align with current NAM-focused regulatory expectations.

This toxicity pilot study offers an entry point to assess whether your therapeutic compound elicits morphological damage or initiates early inflammatory responses when injected into human subcutaneous tissue. Based on ex vivo biostabilized human skin,  this New Approach Methodology provides decision-enabling data that support early safety assessment and guide downstream development.

Local toxicity assessment in human HypoSkin models

This feasibility study is recommended when:

You are new to Genoskin’s technology and want to validate its relevance to your program.
You need early human-based data to support internal decision-making.
You require preliminary evidence to justify a larger, multi-donor investigation.
You are looking for preliminary data before setting-up a larger program to de-risk several therapeutic candidates

Analysis & readouts

Tissue viability: Hematoxylin & Eosin (H&E) staining.
Immune response assessment: Multiplex cytokine analysis

Specific questions addressed in the pilot study

Does the compound alter epidermal or dermal morphology following injection?
Does the compound trigger cytokine release relative to vehicle control?
Are early immune signals detectable between days 2–5 post-injection?
Are culture media cytokine trends supportive of further investigation or a change in readouts?

Experimental workflow

Genoskin
Detect injection site reaction and local tolerance with a pilot study using New Approach Methodology

Deliverables & important information

Genoskin

Deliverables included in the pilot study

Data package:

  • Immunohistochemistry (H&E) image files
  • Cytokine analysis datasets
  • Presentation-ready results
  • Raw data available on demand

Final report:

  • Full data interpretation
  • Delivered as a slide deck
  • Alternate formats available upon request prior to study approval

Biological variability

Genoskin’s models are sourced from healthy human donors and naturally reflect genetic and molecular variability found in human skin.

A pilot study is designed as an initial feasibility test to observe how your molecule behaves in humannskin and to help identify the most relevant readouts for assessing local toxicity. For statistically robust and reliable conclusions, a follow-up study should be planned with multiple donors and an appropriate number of models per endpoint.

Scope & limitations of use

The biological materials and results generated in this study are intended for research purposes only.
Use of the materials excludes:

  • Any clinical and/or medical applications
  • Attempts to discover composition, manufacturing processes, or trade secrets behind the materials

Ethical sourcing & compliance

All biological materials used in this study are obtained from human donors under informed consent authorization.
Full terms and conditions can be accessed here: Terms & conditions.

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