Key Considerations for Development and Production of Vaccine Products - Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate in

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Key Considerations for Development and Production of Vaccine Products
Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.


BioPharm International Supplements
Volume 25, Issue 3, pp. s28-s34

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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