Quality Controls of Autologous Skin Products According to European GMP Guidelines

The production of Cultured Epithelial Autografts (CEAs), autologous keratinocyte-sprays, and tissue-engineered skin substitutes in hospital-based laboratories is considered an Advanced Therapy Medicinal Product (ATMP). The production of ATMPs in Europe has to follow GMP (Good Manufacturing Practice) conditions and is regulated by Regulation 1394/2007 and Commission Directive 2009/120/EC. European regulation establishes the need of carrying out a complex process of characterization and quality controls during production, in order to release these products for clinical use. They are carried out at each critical stage of production: reception of the skin biopsy, extraction of keratinocytes and/or fibroblasts, media change, cell growth, cell passaging, and on the finished products. Here, we describe the production for autologous skin products at each critical stage: harvesting and biopsy reception, isolation of keratinocytes and fibroblasts, cell culture, and preparation of the final product.