West Nile Virus inactivation by the solvent/detergent steps of the second and third generation manufacturing processes for B‐domain deleted recombinant factor VIII

West Nile Virus (WNV) was immediately and completely inactivated to below assay detection limits upon addition of solvent/detergent (S/D) to intermediate process pools of second and third generation B‐domain deleted recombinant Factor VIII (BDDrFVIII; ReFacto, Wyeth, Cambridge, MA, USA). We verify that the S/D step provides robust enveloped virus inactivation (>5 log10) and functions as a WNV barrier.

[1]  M. Leonard,et al.  The manufacturing process for B-domain deleted recombinant factor VIII. , 2001, Seminars in hematology.

[2]  A. Losikoff,et al.  Removal of viruses from human intravenous immune globulin by 35 nm nanofiltration. , 1998, Biologicals : journal of the International Association of Biological Standardization.

[3]  D. Gubler,et al.  West Nile encephalitis: an emerging disease in the United States. , 2001, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  C. Feit,et al.  Detection of retroviral particles in hybridomas secreting monoclonal antibodies , 2005, Medical Microbiology and Immunology.

[5]  Robert Magnusson,et al.  Development and validation of an affinity chromatography step using a peptide ligand for cGMP production of factor VIII , 2004, Biotechnology and bioengineering.

[6]  D. Metselaar [Arboviruses]. , 2012, Nederlands tijdschrift voor geneeskunde.

[7]  M. Jernberg,et al.  Viral safety of B-domain deleted recombinant factor VIII. , 2001, Seminars in hematology.

[8]  Dry Powder Inhalers,et al.  The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit , 1996 .

[9]  E. Lennette,et al.  Diagnostic Procedures for Viral, Rickettsial and Chlamydial Infections , 1989 .

[10]  M. Wiebe,et al.  Inactivation of viruses in labile blood derivatives. I. Disruption of lipid‐enveloped viruses by tri(n‐butyl)phosphate detergent combinations , 1985, Transfusion.

[11]  Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline. , 1998, Developments in biological standardization.

[12]  M. Wiebe,et al.  Inactivation of viruses in labile blood derivatives. II. Physical methods , 1985, Transfusion.

[13]  T. Charlebois,et al.  Viral safety of recombinant factor IX. , 1998, Seminars in hematology.