Validación del sistema automatizado bact/alert en el control microbiológico de productos celulares de terapias avanzadas

  1. Ruiz García, Antonio
  2. Jorge Guerrero Calvo
  3. Natividad Fernández Porcel
  4. Olga Espinosa Ibáñez
  5. Antonio Manuel Lizana Moreno
  6. Ana Fernández González
  7. Salvador Arias Santiago
Journal:
Actualidad médica

ISSN: 0365-7965

Year of publication: 2016

Tome: 101

Issue: 797

Pages: 24-29

Type: Article

DOI: 10.15568/AM.2016.797.OR04 DIALNET GOOGLE SCHOLAR lock_openDIGIBUG editor

More publications in: Actualidad médica

Abstract

Objective. Quality control to demonstrate that a product is free from adventitious microbial agents is a key aspect of process control and quality evaluation of all cell medicinal preparations and in tisular engineering. Evaluate the validation of the BacT/ALERT Blood Culture System for the microbial control of mesenchymal cells for cell therapy according European Pharmacopoeia (EU.PH), 2.6.27. “Microbiological control of cellular products” (1). Method. Blood culture bottles were challenged with 4 replica of 30 cfu, 5 replica of 15 cfu and 5 replica of 6 cfu of the test microorganisms. Test were also carried out in the presence in each contaminated culture bottle of 400.000 mesenchymal cells. This method has been compared with the reference method for Sterility of the EU.PH (2). Specificity was tested inoculating 5 replicas of broth culture media with 400.000 cells without microorganisms. Results. All bottles challenged with mesenchymal cells without microorganisms remained negative after 7 days of incubation. All inoculated bottles with aerobic and anaerobic bacterial strains were flagged as positive for the system, in case of low inoculum (6 cfu) in less than 36 hours. Candida inoculated bottles (6 cfu) were detected in less than 48 hours and Aspergillus (6 cfu) in less than 72 hours. There were no significant differences in the detection time between bottles inoculated with and without the presence of mesenchymal cells. Conclusion: The BacT/ALERT blood culture detection system and is a reliable method for detection of microbial contamination of mesenchymal cells medicinal products that fulfils the requirements of the EU PH, 2.6.27, for the microbiological control of cellular products.

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