4.3 Article

Challenges of running a GMP facility for regenerative medicine in a public hospital

Journal

REGENERATIVE MEDICINE
Volume 12, Issue 7, Pages 803-813

Publisher

FUTURE MEDICINE LTD
DOI: 10.2217/rme-2017-0051

Keywords

advanced therapy medicinal products; cell therapy; GMP; investigational medicinal products; regenerative medicine; stem cells

Funding

  1. Fondazione Il Sangue
  2. European Union [223236, 241879, 733288, 668350]
  3. H2020 Societal Challenges Programme [668350, 733288] Funding Source: H2020 Societal Challenges Programme

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Advanced therapy medicinal products represent a new generation of medicinal products for regenerative medicine. Since the implementation of the EU regulation for this innovative class of drugs, the academic and hospital institutions have played a central role in their development and manufacture. For these institutions that are not familiar with the industrial context, being in compliance with the pharmaceutical standards is extremely challenging. This report describes how we dealt with some specific issues during our hospital-based GMP experience. Furthermore, we identify as a future perspective the consistent stimulating contribution that a public entity can ensure for advanced therapy medicinal product development and licensing.

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