Ultra-rapid microbial detection in cell & gene therapy products: the closest you can be to real-time release

Cell and Gene Therapy Insights 2023; 9(2), 207;

DOI: 10.18609/cgti.2023.31

Published: 26 March 2023
FastFacts
Félix Montero-Julian


Watch the video or read the poster to learn about:

  • Same-day sterility results for cell-based products (<6-h time-to-result)
  • Sensitivity that is equivalent to compendial methods
  • Low testing volume (0.1–2 mL sample)
  • Detection of microorganisms in a product containing a very high concentration of mammalian cells (106– 107 cell/mL)


Félix Montero-Julian is the Scientific Director for the Pharma Quality Control Business of bioMérieux (Lyon, France). Félix has over 25 years of experience in industrial and clinical diagnostics, and previously served as the Chemunex Ivry-sur-Seine site & R&D Director in bioMérieux. Félix is a member of different scientific organizations, such as the Parenteral Drug Association (MD, USA), and served as an expert in a panel for the Development of Compendial Rapid Sterility Tests for the US Pharmacopeia (MD, USA). Félix has been, and continues to be, extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He is a prominent speaker at congresses and conferences and a regular contributor to bioMérieux scientific white papers. Félix has extensive technical experience that includes the development of in vitro diagnostic and research use reagents and applications, cell and tissue culture systems, alternative and rapid microbiological methods, sterility testing, Mycoplasma detection, compendia methods, and cell and gene therapy processes.