These courses provided advice and hands-on selleck chemicals experience in quality processes and procedures, laboratory and production scale process development and validation, and GMP production. In addition, a three-year consultancy agreement has been signed with NVI to cover the production process of egg-based influenza vaccine in IVAC’s new facility, including on-site process validation, quality control and assurance, efficacy monitoring and (pre)clinical

trials. IVAC staff have also been trained in the installation, operation and maintenance of equipment by the relevant suppliers, along with concepts of safety and biosecurity related to specific machinery and for the chicken farm. Key personnel Galunisertib cell line responsible for managing the chicken farm have also been trained in chicken husbandry by the Ministry of Agriculture in Hanoi. Applying our extensive knowledge in the manufacture and quality control of vaccines to published data, we succeeded in developing an A(H5N1) candidate vaccine in our research laboratory and have made significant progress over the last two years towards our goal to produce a pandemic influenza

vaccine for the Vietnamese market. We have built, equipped and expanded a manufacturing facility to be able to produce >1 million doses per year as well as an operational poultry farm without the support of technology partner, and with only US$3.5 million seed funding from WHO to supplement the US$ 300 000 we were able to invest from our own funds. We have also managed to meet our original time frame despite challenges posed, for example, by the delayed arrival of funds and import authorization for materials. By January 2011, when eggs from our chicken farm become available, we will initiate clinical studies to develop H1N1 and H5N1 vaccines. Subject to satisfactory Urease results, IVAC plans to apply for registration and licensing of a monovalent H1N1 vaccine by the end of 2012, followed shortly

afterwards by a monovalent H5N1 vaccine. At least 200,000 doses of H1N1 and 500,000 doses of H5N1 influenza will be stockpiled in 10-dose vials for essential populations in Viet Nam (elderly, health-care workers, pregnant women and persons at higher risk). IVAC has decades of experience of working with leading vaccine R&D entities from all continents. A welcome effect of the WHO project has been interest from further international partners to support our research and expand our skills. We were selected, for example, as part of a grant from the USA to support, in particular, environmental aspects of our pandemic influenza project, and the development of Phases I and II safety and immunogenicity studies in human clinical trials of our vaccine.