REFERENCES
1. Fetzer S, BioPharm. Int.
21 (1), s1–s6 (2008).
2. Vaccine http://Ethics.org/, "The Vaccine Industry— An Overview,"
http://www.vaccineethics.org/issue_briefs/industry.php, accessed Feb. 2012.
3. Kalorama Information,
http://www.kaloramainformation.com/, accessed June 22, 2009.
4. PhRMA, "Report on Biotechnology Medicines in Development", 2008, http://www.pharma.org/, accessed June 22, 2009.
5. G. Dietrich et al., "Manufacturing of Vaccines," In New Generation Vaccines, M.M. Levine et al., Eds., (Marcel Dekker, New York, 2004) pp. 1081–1091.
6. P. Gagnon GEN
28 (14), (2008).
7. J.B. Ulmer, U. Valley, and R. Rappuoli, Nat. Biotechnol.
24, 1377–1383 (2006).
8. B. Metz et al., Vaccine
20, 2411 (2002).
9. S. Becht, X. Gu, and X. Ding, Biopharm Int. 20 (8), 1–7 (2007).
10. H. S. Seo et al., Vaccine
26, 4138 (2008).
11. N.W. Baylor, supplement to BioPharm Int.
20(8), 6–15 (2007).
12. S. Scott, BioProcess Int.
8 (s8), 36–42 (2010).
13. D.I. Freedberg, "Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines
and Blood Products: NMR Spectroscopy and Light Scattering,"
http://www.fda.gov/biologicsbloodvaccines/scienceresearch/biologicsresearchareas/ucm127270.htm.
14. G. Healy, "Vaccine production and development: The challenges of realizing a future free from disease," Microbiologist
March 28–30 (2006).
15. A.S. Rathore and H. Winkle, Nat. Biotechnol.
27, 26–34 (2009).
16. A.S. Rathore AS, Trends Biotechnol.
27, 546–553 (2009).
17. "Q&A: Good Manufacturing Practice (GMP)," http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp&jsenabled=true.
18. FDA, General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (Rockville, MD, Dec. 2011).
19. Meningitis Vaccine Project, "Regulatory and prequalification pathways,"
http://www.meningvax.org/regulatory-prequalification.php. accessed Feb. 2012.
20. K.J. Rambhia et al., Biodefense Strategy, Practice, and Science
8 (4), 321–330 (2010).
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