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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.

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Quality Controls of Autologous Skin Products According to European GMP Guidelines

  • 实验方案

  • 发表日期：

    2025年

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  • Rocio García de la Cruz Valencia,
  • Gloria Carmona Sánchez,
  • Céline Auxenfans,
  • Jean-François Brunet,
  • Ana Fernández González,
  • Vivienne Woodtli,
  • Alexandra Karström,
  • Marina Trouillas

摘要

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.