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Manufacturing capability key to global health advances


Progress in developing AIDS vaccines is focussing attention on the challenges involved in producing millions of doses for developing nations.

The international community has launched a massive campaign to combat the AIDS epidemic and other major diseases raging throughout the third world. Last year, numerous international conferences highlighted the need for a huge investment in the development of new vaccines and medicines to combat AIDS, malaria and tuberculosis (TB). At the World AIDS Conference in Barcelona, Spain (July 2002), pharmaceutical manufacturers announced additional price reductions for AIDS therapies and increased support for research into new treatments. Further discussion of these issues took place at the Johannesburg World Summit on Sustainable Development in September. World AIDS Day in December generated pledges from the West to increase support for international disease prevention and treatment programmes.

Manufacturing gains attention

Up until now, efforts to combat AIDS and other diseases have focussed largely on increasing public access to existing therapies, and investing in research into new compounds and biomedical approaches that are likely to lead to new vaccines and disease treatments. Donor organizations and health foundations have been expanding research and development (R&D) programmes and establishing international clinical trial networks to study promising therapies. Pharmaceutical companies are involved in tests of 14 vaccine candidates, including one that has begun Phase III clinical trials in Thailand, the US and Europe.

As programmes to develop new vaccines and therapies show promise, health experts are recognizing the need to plan to manufacture any new treatments on a global scale. To be able to produce a vaccine as soon as it is licensed, plant construction has to begin before sponsors have assurance that a test product will work. Construction of a vaccine manufacturing plant that meets GMP (good manufacturing practice) standards normally requires several years and at least $50 million to build. However, the numbers are much higher for an AIDS vaccine that would be needed by much of the world.

Many of the difficulties related to new vaccine production have been apparent for years, as international health organizations have struggled with vaccine production, distribution and safe administration challenges involved in expanding third-world access to existing vaccines and medicines (see sidebar “Innovation spurs access”). Drug manufacturing capability still barely exists in most third-world

Source : accessmylibrary.com



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