International validation of novel pyrogen tests based on human monocytoid cells.

  title={International validation of novel pyrogen tests based on human monocytoid cells.},
  author={Sebastian Hoffmann and Anja Peterbauer and Stefanie Schindler and Stefan Fennrich and Stephen Poole and Yogesh M Mistry and Thomas Montag-Lessing and Ingo Spreitzer and Bettina Loeschner and Mirjam van Aalderen and Rogier Bos and Martin Gommer and Ria Nibbeling and G Werner-felmayer and Petra Loitzl and Thomas Jungi and Marija Brcic and Peter Br{\"u}gger and Esther Frey and Gerard Bowe and Juan Casado and Sandra Coecke and J de de Lange and Bente Mogster and Lisbeth Meyer Naess and Ingeborg Sundsvalen Aaberge and Albrecht Wendel and Thomas Hartung},
  journal={Journal of immunological methods},
  volume={298 1-2},
It is a requirement that parenteral medicines be tested for pyrogens (fever causing agents) using one of two animal-based tests: the rabbit pyrogen test and the bacterial endotoxin test. Understanding the human fever reaction has led to novel non-animal alternative tests based on in vitro activation of human monocytoid cells in response to pyrogens. Using 13 prototypic drugs, clean or contaminated with pyrogens, we have validated blindly six novel pyrogen tests in ten laboratories. Compared… CONTINUE READING
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