Broadening Our Expectations for Viral Safety Risk Mitigation

References

1. 1.↵
   FDA. Points to Consider in the Characterization of Cell Lines Used To Produce Biologicals, 1987 and 1993.
2. 2.↵
   CPMP/BWP/268/95. Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, 1996.
3. 3.↵
   FDA. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997.
4. 4.↵
   WHO. Requirements for the Use of Animal Cells as In Vitro Substrates for the Production of Biologicals. 1998.
5. 5.↵
   ICH Q5A. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1999.
6. 6.↵
   EMEA/CHMP/BWP/398498/2005. Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products, 2008.
7. 7.↵
   FDA. Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, 2010.
8. 8.↵
   1. Garnick R. L.

   Viral safety and evaluation of viral clearance from biopharmaceutical products. Dev. Biol. Stand. (Basel) 1996, 88, 49–56.

   OpenUrl
9. 9.↵
   1. Hendricks L. C.,
   2. Jordan J.,
   3. Yang T.-Y.,
   4. Driesprong P.,
   5. Haan G. J.,
   6. Viebahn M.,
   7. Mikosch T.,
   8. Van Drunen H.,
   9. Lubiniecki A. S.

   Apparent virus contamination in biopharmaceutical product at Centocor. PDA J. Pharm. Sci. Technol. 2010, 64 (5), 471–480.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    Genzyme presentation in this proceedings.