The Avian EB66® Cell Line, Application to Vaccines, and Therapeutic Protein Production

References

1. 1.↵
   Points to consider in the characterization of cell lines used to produce biologicals. CBER, FDA, 1993.
2. 2.↵
   ICH Topic Q5A—Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. EMA CPMP/ICH/295/95, 1997.
3. 3.↵
   ICH Topic Q5D—Quality of biotechnological products: derivation and characterization of cell substrates used for production of biotechnological/biological products, EMA CPMP/ICH/294/95, 1998.
4. 4.↵
   WHO Technical Report Series No. 878, 1998. Annex 1: Requirements for the use of animal cells as in vitro substrates for the production of biologicals.
5. 5.↵
   Ph. Eur. 5.2.3. Cell substrates for the production of vaccines for human use.
6. 6.↵
   CBER's letter to the manufacturers dated 14 December 1998: request for PCR-based reverse transcriptase (PBRT) assays to characterize cell substrates.
7. 7.↵
   Characterization and Qualification of Cell Substrates and other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases—Draft Guidance, September 2006.
8. 8.↵
   1. Olivier S.,
   2. Jacoby M.,
   3. Brillon C.,
   4. Bouletreau S.,
   5. Mollet T.,
   6. Nerriere O.,
   7. Angel A.,
   8. Danet S.,
   9. Souttou B.,
   10. Guehenneux F.,
   11. Gauthier L.,
   12. Berthomé M.,
   13. Vié H.,
   14. Beltraminelli N.,
   15. Mehtali M.

   EB66 cell line, a duck embryonic stem cell–derived substrate for the industrial production of therapeutic monoclonal antibodies with enhanced ADCC activity. mAbs 2010, 2 (4), 1–11.

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