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A Recognized Rapid Microbiological Method for Cell & Gene Therapy Products: Regulation & Industrial Application

Cell & Gene Therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat diseases such as cancer, rare diseases, and autoimmune disorders.

Those therapies, based on living cells, have short shelf lives, are available in low volumes and cannot be sterilized by filtration or irradiation. Microbiological examination of cell-based products is critical to ensure safety prior to patient infusion.

The harmonized chapters of the compendial sterility test method – USP <71>, Ph.Eur. 2.6.1, JP 4.06– are not adapted for C&GT products due to three major constraints: 

  • Time to Result
  • Method Subjectivity
  • Matrices Compatibility

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