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

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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.

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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.

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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.

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