Better science through ethical sourcing

From donated human skin to innovative human skin models

Genoskin

Human skin tissue is classified as a biological sample, and its collection and use must comply with strict legal and ethical requirements. To ensure this, Genoskin works exclusively with hospitals and clinics under secure Biological Sample Transfer contracts that safeguard both donor confidentiality and research integrity. These contracts mandate that each sample is collected following rigorous protocols and accompanied by anonymized donor information allowing us to maintain full traceability:

Donor age
Donor gender
Known skin diseases & conditions
Used medication: corticoïds, steroids, topical antibiotics, immunosuppressing or immunomodulating agents

Collection

Our human skin samples are collected right after surgery and immediately transported to Genoskin’s facilities.

Safety tests

Before using a skin sample, our skin experts conduct safety tests for Hepatitis B and C, as well as HIV-1 and HIV-2. Only negative samples are used to produce our skin models.

Production

Production of human skin models occurs within 24 hours after surgery. In the interval between donor surgery and model production, the skin samples are maintained at optimal temperature.

Legal guidelines on the use of donated human skin tissue

Genoskin

Animal experiments have been widely used to assess toxicity and safety and to support the development of new pharmaceutical, chemical or cosmetic products. However, increasing awareness of the fate of laboratory animals has encouraged lawmakers to restrict the use of animals during testing procedures:

The ban on animal experiments to test cosmetic products in the EU & a growing number of countries worldwide
The Three R principle on the reduction of animal experiments
The OECD guidelines on the use of alternative testing methods
The REACH guidelines on chemical products

Legal & ethical compliance

Genoskin fully complies with ethical and legal standards:

Informed consent is always obtained prior to cosmetic surgical procedures such as abdominoplasties, brachioplasties or facelifts.
All donors support the use of their skin for research, in line with the Declaration of Helsinki.
Genoskin has obtained the required authorizations from the French Ministry of Research and Higher Education and Ethics Committees (Comité de Protection des Personnes or CPP).
Genoskin established Biological Sample Transfer Contracts with hospitals and clinics to ensure regulatory compliance.

Human data to de-risk drug development

Genoskin

At Genoskin, we provide innovative, animal-component-free (ACF) / xeno-free (XF) human skin models as reliable alternatives to animal testing. Instead of being discarded, the collected human skin is transformed into scientifically valuable tools that:

Replace in vivo animal experiments for skin toxicity and efficacy studies
Bridge the gap between in vitro and in vivo clinical testing by using real human skin tissue

Our models support the biopharmaceutical, chemical, & cosmetic industries in developing safe and effective products, while actively reducing animal testing.

Our approach aims to improve drug development by generating relevant human data instead of relying on animal models. By using human skin tissue, our test platforms assess the immunogenicity and immunotoxicity of drugs and vaccines across different administration routes before clinical trials. This strategy provides more predictive results, helping science and industry move forward responsibly.

HypoSkin, injectable human skin model made from real human skin tissue samples and designed to study human response to biologics and other therapies

High-quality human skin data

Processed in compliance with ISO 9001 standards

Genoskin

To ensure our models and processes meet the standards and quality requirements of our customers, Genoskin SAS has obtained the ISO9001 certification. This validates the quality of our process management to deliver consistent, high-quality skin models and R&D services for the development of new drugs and products requiring human skin testing, with a team committed to being a trustworthy preclinical research partner. All our activities are documented in our quality assurance manual and periodically reviewed.

Since 2017, Genoskin’s main facility in France has been ISO9001:2015 certified, ensuring customers receive consistently high-quality products & services.

ISO9001 is a certifiable quality management system that can be used by any organization, regardless of its field of activity. This standard is based on several quality management principles, including:

The motivation and implication of top management
Strong customer focus
The process approach
Continual improvement

Certified quality processes

Genoskin’s activities are divided into processes and monitored by demanding performance indicators

Genoskin

A robust documentary system oversees all of the company’s activities. Regular internal audits are carried out in parallel with external audits to ensure the proper application of our standard operating procedures and to maintain continuous improvement. The company is audited by AFNOR, an external certification body, yearly. All processes are verified (Sourcing/Biobanking, Production, Services, R&D, Sales, Quality, etc.). These audits are organized over a 3-year cycle: 1 initial audit and 2 follow-up audits.

For more information, please don't hesitate to contact us