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Environmental monitoring in stem cell banks

  • Fernando Cobo
  • Glyn N. Stacey
  • José Luis Cortés
  • Ángel Concha
Mini-Review

Abstract

The processing of stem cell lines for application in human therapy requires a physical environment in which air quality (i.e., the number of airborne particles) is controlled to minimize risk of contamination. The processing facility should be constructed and operated to minimise the introduction, generation and retention of particles and microorganisms. A formal program of environmental monitoring should be maintained in each stem cell bank to specify and assess key factors and their influence on the microbiological quality of the process and product. This program should assure the manipulation of cells involved in the derivation of stem cell lines and their culture under established limits for airborne particles and for microbial contamination of the air and surfaces. Environmental monitoring should also address the regulatory requirements in the countries in which the cells will be used. The monitoring programme will depend on local conditions in each processing centre or cell bank. Each centre will need to evaluate its specific needs and establish appropriate monitoring procedures which should not become intrusive to the extent that they might compromise the quality of the cell banks or products.

Keywords

Stem Cell Line International Standard Organisation hESC Line European Pharmacopoeia United States Pharmacopoeia 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgement

Ms. Angela Barnie is acknowledged for the translation of the manuscript.

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Copyright information

© Springer-Verlag 2006

Authors and Affiliations

  • Fernando Cobo
    • 1
  • Glyn N. Stacey
    • 2
  • José Luis Cortés
    • 1
  • Ángel Concha
    • 1
  1. 1.Stem Cell Bank of Andalucía (Spanish Central Node)Hospital Universitario Virgen de las NievesGranadaSpain
  2. 2.UK Stem Cell BankNational Institute for Biological Standard and ControlHertfordshireUK

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