5 December 2025 By Hervé Huchon Comments are Off

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 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 early immune activation in human skin is essential to de-risk injectable therapeutics before advancing development. Genoskin’s HypoSkin® platform provides ex vivo, immunocompetent human skin that preserve 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 wish to assess tolerability or immunotoxicity before a larger toxicology or ISR investigation.
You require preliminary evidence to justify a larger, multi-donor investigation.

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
Toxicity pilot study experimental workflow

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 slid 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.
To ensure statistical relevance, Genoskin strongly recommends using 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.

Request your pilot study plan

Get the full experimental design and tailored quote to see how this pilot fits your development strategy.

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