How we make cell therapy in Italy

Drug Des Devel Ther. 2015 Aug 20;9:4825-34. doi: 10.2147/DDDT.S80403. eCollection 2015.

Abstract

In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

Keywords: advanced therapy medicinal product; good manufacturing practices; stem cells.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Air Conditioning / standards
  • Air Microbiology / standards
  • Asepsis / standards
  • Budgets
  • Cell Culture Techniques / economics
  • Cell Culture Techniques / standards*
  • Environmental Monitoring / standards
  • Facility Design and Construction / standards
  • Humans
  • Italy
  • Laboratories / economics
  • Laboratories / standards*
  • Practice Guidelines as Topic
  • Quality Control
  • Stem Cell Transplantation / economics
  • Stem Cell Transplantation / standards*
  • Stem Cells / physiology*