The Changing Landscape of Global Vaccine Development and Market Potential - - BioPharm International

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The Changing Landscape of Global Vaccine Development and Market Potential


BioPharm International
Volume 20, Issue 10

Tuberculosis Vaccines

The current tuberculosis (TB) vaccine Mycobacterium bovis bacillus Calmette-Guerin (BCG) provides efficient protection against TB in newborns, but does not prevent the establishment of latent TB or reactivation of pulmonary disease in adults. Current vaccine development focuses on two approaches: (1) Replacing BCG with a more effective vaccine or (2) boosting BCG with a booster vaccine which takes advantage of BCG priming vaccination in childhood, and which is given to increase the immune response and prolong immunity to an adult population.32,33 Several vaccines are in various stages of early clinical development. rBCG30 is a recombinant BCG vaccine (to replace GCG) under clinical studies as a BCG replacement. It overexpresses the surface antigen Ag85B, which appears to increase immune response to this important antigen. MVA85A is a modified vaccine virus Ankara (MVA) strain expressing antigen 85A (to boost BCG). It induces strong immune responses, particularly in previously BCG-vaccinated individual. Ag85B-ESAT6 is made up of two secreted antigens Ag85B and ESAT6. It has shown promise both parenterally and through the mucosal route.

NEW OPPORTUNITIES

New technologies include recombinant cell culture methodologies, transgenic systems to produce edible vaccines, new conjugation methods, delivery systems free of needles, disposable manufacturing technologies and stable formulations that will enable developing countries to transport or store the vaccines at ambient temperatures. DNA-based vaccines are cost-effective, can be made faster, are stable at higher temperatures, can be delivered by needle free systems and highly suitable not only for developing countries but also to respond to pandemic outbreaks or bioterrorism, given the shorter scale-up time. The development of vaccines for Alzheimer's, cancer, drug addiction, HIV, multiple sclerosis, tropical diseases, and autoimmune disorders such as diabetes, lupus erythematosus, and arthritis will be the future focus for the scientific community and biotechnology companies globally. The opportunities, possibilities, and market potential are so great that many new players will enter the field to shape the changing landscape of vaccine development.

Hank Liu, PhD, is the associate director of manufacturing sciences and technologies at Wyeth Biotech, Pearl River, NY 845.602.2043,
.

REFERENCES

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2. Moingeon P, editor. Vaccines: Frontiers in design and development. Norwich, UK: Horizon Bioscience; 2005.

3. Somasekhar G, Chao SB. Vaccine Technology. Kirk-Othmer Encyclopedia of Chemical Technology. 2006;25:486-512.

4. Aguilar JC, Rodriguez EG. Vaccine adjuvants revisited. Vaccine. 2007;25:3752-3762.

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6. Guy B. The perfect mix: recent progress in adjuvant research. Nature Rev Microbiol. 2007;5:505-517.

7. Rios M. Process consideration for cell-based influenza vaccines. Pharm Technol. 2006;April:46-56.

8. Hehme N, et al. Pandemic preparedness: lessons learned from H2N2 and H9N2 candidate vaccines. Med Mirobiol. Immunol. 2002;191:203-208.

9. Wadman M. Race is on for flu vaccines. Nature. 2005;438:23.

10. Babai I, et al. A novel liposomal influenza vaccine (INFLUSOME-VAC) containing hemagglutinin-neuraminidase and Il-2 or GM-CSF induces protective anti-neuraminidase antibodies cross-reacting with a wide spectrum of influenza A viral strains. Vaccine 2001;20:505-515.

11. Nabel GJ. Mapping the future of HIV vaccines. Nature Rev Microbiol. 2007;5:482-484.

12. Nkolola JP, Essex M. Progress towards an HIV-1 subtype C vaccine. Vaccine. 2005;24:391-401.


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