Quality

All operations within A-SKIN are under the purview of an effective Quality System to maintain compliance with the applicable regulations and to ensure control and assurance that only high quality research, data and safe products will leave A-SKIN.

A-SKIN has been granted a GMP license and a Tissue Licence (Tissue Establishment) by the Ministry of Health in The Netherlands (IGZ). Human tissue processed at A-SKIN is derived from donors who fulfill all the requirements of the European Directives for quality and safety of human tissues and cells (2004/23EU 2006/86EU and 2006/17EU). This implies that tissue products processed by A-SKIN are sterile and fulfill all the quality requirements mentioned in the European Directives for quality and safety of tissues and cells. Standard operating procedures, in process controls and release testing are in place. Training programs are established and maintained on all levels of the organization and include basic GMP, various function specific training depending on activities and position within the organization

The impact of our work on society is of great value to A-SKIN and its team. Importantly, A-SKIN’s in vitro human skin models enables the replacement of animal studies in fundamental and preclinical research. The primary human skin tissue we use to generate our in vitro skin models are all collected according to legal guidelines.

Ethics non animal testing - 3 R’s: reduce animal experimentation

In 1959 William Russell and Rex Burch in introduced the 3R’s principles (Replacement, Reduction and Refinement) as a framework for humane animal research. They have subsequently become embedded in national and international legislation regulating the use of animals in scientific procedures. A decisive contribution to this was the 7th Cosmetic Directive, which requires the replacement of cutaneous absorption animal testing and chemical side affect tests with in vitro test systems by 2009. Laboratory prepared skin equivalents represent a real alternative.

Primary donor material

All primary human skin cells from healthy donors used by A-SKIN are isolated from surplus tissue collected according to article 467 of the Dutch Law on Medical Treatment Agreement and the Code for proper Use of Human Tissue of the Dutch Federation of Biomedical Scientific Societies. All primary skin samples from diseased donors used by A-SKIN are obtained with informed consent.

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