Application of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus Vaccines

References

1. 1.↵
   ICH Q5D. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products, July 1997.
2. 2.↵
   ICH Q5A (R1). Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, September 1999.
3. 3.↵
   Points To Consider in the Characterization of Cell Lines Used To Produce Biologicals, U.S. Food and Drug Administration, July 1993.
4. 4.↵
   Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, February 2010.
5. 5.↵
   European Pharmacopoeia. General Chapter 5.2.3, Cell Substrates for the Production of Vaccines for Human Use.
6. 6.↵
   European Pharmacopoeia. General Chapter 2.6.16, Tests for Extraneous Agents in Viral Vaccines for Human Use.
7. 7.↵
   1. Plavsic Z. M.,
   2. Bolin S.

   Resistance of porcine circovirus to gamma irradiation. BioPharm. 2001, 14 (4), 32–37.

   OpenUrl
8. 8.↵
   European Pharmacopoeia. General Chapter 5.2.2, Chicken Flocks Free from Specified Pathogens for the Production and Quality Control of Vaccines.
9. 9.↵
   United States Department of Agriculture. Veterinary Services Memorandum No. 800.65, Eggs and Chickens for Production of Veterinary Biological Products, September 2002.
10. 10.↵
    Committee for Proprietary Medicinal Products (CPMP). Points to Consider on the Development of Live Attenuated Influenza Vaccines, EMEA/CPMP/BWP/2289/01, February 2003.
11. 11.↵
    1. Pleschka S.,
    2. Jaskunas R.,
    3. Engelhardt O. G.,
    4. Zurcher T.,
    5. Palese P.,
    6. Garcia-Sastre A.

    A plasmid-based reverse genetics system for influenza A virus. J. Virol. 1996, 70 (6), 4188–4192.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Fodor E.,
    2. Devenish L.,
    3. Engelhardt O. G.,
    4. Palese P.,
    5. Brownlee G. G.,
    6. García-Sastre A.

    Rescue of influenza A virus from recombinant DNA. J. Virol. 1999, 73 (11), 9679–9682.

    OpenUrlAbstract/FREE Full Text