7. Gavin D. Perspectives on potency assays for complex biological products. 2007 WCBP, CMC Forum on Bioassays, 2007 Jan 28;
8. WHO. Immunization, vaccines and biologicals: strategic plan 2006–2009. Geneva: 2005 Dec.
9. WHO. Recommendations for the preparation, characterization and establishment of international and other biological reference
standards, final draft. Adopted by the 55th meeting of the WHO expert committee on biological standardization. Geneva: 2004
10. International Conference on Harmonization. Q6B, Specifications: Test procedures and acceptance criteria for biotechnological/biological
products. Geneva, Switzerland:1999 Mar 10.
11. ICH. Q5C, Quality of biotechnological products: stability testing of biotechnological/biological products. Geneva: 1995
12. ICH. Q5D, Derivation and characterization of cell substrates used for production of biotechnological/biological products.
Geneva: 1997 July 16.
13. ICH. Q5E, Comparability of biotechnological/biological products subject to changes in their manufacturing process.Geneva:
2004 Nov 18.
14. Girard MP et al. A review of human vaccine research and development: Malaria. Vaccine. 2007; 25:1567–1580.