New Approach Methodology

ISR Platform – Toxicity pilot study

Detect Injection Site Reactions in Human Skin before they appear in your clinical trial

Request Your Pilot Study Plan See how it works

A 5-day ex vivo pilot study using living human skin to generate early local toxicity and immune response data for your injectable therapeutic.
One donor. Clear safety signals. NAM-aligned.

Genoskin
The Challenge

Injection site reactions are the #1 reported adverse event for biologics

If you’re developing an injectable biologic, monoclonal antibody, ADC, or peptide therapeutic, injection site reactions are a foreseeable risk. They remain one of the most frequently reported adverse events in clinical trials for subcutaneous and intradermal products.

Standard pre-clinical models like murine skin lack the structural complexity, immune cell composition, and barrier architecture of human skin. Reactions that go unnoticed in animals can surface in first-in-human studies, leading to clinical holds, protocol amendments, or costly reformulation cycles.

What if you could detect these signals earlier in actual human tissue before committing to a full preclinical program?

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

Study Overview

Evaluate local toxicity using biostabilized human skin

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.

What We Measure

Analysis & readouts

READOUTS INCLUDED

Tissue viability: Hematoxylin & Eosin (H&E) staining

Immune response assessment: Multiplex cytokine analysis

SPECIFIC QUESTIONS ADDRESSED

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?
Process

Experimental workflow

Detect injection site reaction and local tolerance with a pilot study using New Approach Methodology
Typical turnaround: 4–6 weeks from compound receipt to final report delivery, including histopathological assessment, cytokine quantification, and full data interpretation.
What You Receive

Deliverables & important information

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 professional slide deck
Alternate formats available upon request
Clear recommendations on follow-up study design
A note on biological variability: Genoskin’s models reflect the natural genetic diversity of human donors. This pilot is a feasibility screen. For statistically powered conclusions, a follow-up multi-donor study is recommended.

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 human skin and to help identify the most relevant readouts for assessing local toxicity.

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 tissue is sourced from healthy adult donors undergoing elective surgery, under full informed consent and in compliance with applicable bioethics regulations. Genoskin maintains rigorous quality assurance and full traceability across its supply chain. Full terms and conditions can be accessed here: Terms & conditions.
Frequently Asked Questions

Common questions about the pilot study

How is this different from testing in animal skin?

Murine skin differs from human skin in thickness, immune cell repertoire, and barrier function. HypoSkin® preserves full-thickness human skin with native resident immune cells, giving you toxicity data that reflects how your compound will actually behave in patients.

What is the typical turnaround time?

The in-life culture phase is 5 days. Including tissue logistics, histopathology, cytokine quantification, and report preparation, the typical end-to-end timeline is 4 to 6 weeks from compound receipt.

Can I draw reliable conclusions from a single-donor study?

A pilot study is a feasibility screen, not a powered study. It generates early safety signals and identifies the most relevant readouts for a subsequent multi-donor investigation.

How is the tissue sourced?

From healthy adult donors undergoing elective surgery, under full informed consent and ethical approval. Genoskin maintains rigorous quality assurance and traceability across its supply chain.

What types of injectables can be tested?

HypoSkin® has been used to evaluate monoclonal antibodies, bispecific antibodies, ADCs, peptides, oligonucleotides, and gene therapies. If your therapeutic is delivered subcutaneously or intradermally, the platform is likely applicable.

Does this data carry regulatory weight?

The platform is aligned with the FDA Modernization Act 2.0. Pilot data supports internal decision-making. Combined with a multi-donor study, it can contribute to IND-enabling safety packages.
Get Started

Ready to generate early safety data for your injectable?

Tell us about your compound and study objectives. Our scientific team will review your request and respond with a tailored pilot study plan including proposed timeline, readouts, and pricing, typically within 2 business days.

No commitment required. This is a conversation, not a contract.

Study plans designed by Genoskin’s in-house scientific team

Typical response time: 1–2 business days

Your information is confidential and protected

Request Your Pilot Study Plan