Corpus ID: 31895078

[Evaluation of viral safety of a high-purity human factor VIII concentrate submitted to 2 specific virus inactivation treatments (FANDHI)].

@article{Ristol1996EvaluationOV,
  title={[Evaluation of viral safety of a high-purity human factor VIII concentrate submitted to 2 specific virus inactivation treatments (FANDHI)].},
  author={P. Ristol and M. Gensana and J. Fern{\'a}ndez and M. Massot and H. Biescas and A. Darling and J. Jorquera and F. Vericat},
  journal={Sangre},
  year={1996},
  volume={41 2},
  pages={
          131-6
        }
}
AIM To perform a validation study of the production process of a human high purity FVIII concentrate, obtained by affinity chromatography and treated with solvent-detergent and 80 degrees C, 72- hour dry heating in the final vial, in order to demonstrate its viral safety. MATERIAL AND METHODS The ability to inactivate or eliminate viruses was studied in the steps of PEG precipitation, solvent-detergent treatment (6 h 25 degrees C), affinity chromatography and lyophilization plus heating 80… Expand
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