Since early 2008 the former Netherlands Vaccine Intitute established in cooperation with the World Health Organisation an expertise and training center for influenza vaccine production for technology transfer to manufacturers in lower- and middle income countries and emerging economies.
The developed process is an egg-based influenza vaccine production process, suitable for up scaling. The process is at pilot-scale (10.000 eggs), using semi-automated equipment to produce whole virion and split vaccine and follows WHO guidelines (as outlined in the recommendations for the production and control of influenza vaccine (inactivated, WHO TRS 927, 2005). The process to produce seasonal vaccine can be applied to potential pandemic vaccines (in particular H5N1) for public use when appropriate reference strains become available.
Before a first training in 2009 could be realized, a special training facility was designed meeting all Good Manufacturing Practices requirements. Simultaneously, a manufacturing process and all necessary assays were developed and validated. The entire process, including all assays and background information is documented in two course books. Participants of the training courses may use all the Standard Operating Procedures while practising the production process and the associated quality control tests.
Medio 2009 the first training course was held and since then more than 70 participants have been trained in the production facilities and the Quality Control laboratories in Bilthoven. The first one-week workshop handled quality assurance and Good Manufacturing Practices (GMP) aspects including bio safety risk analysis and management. After this workshop, several three week courses were organized in which participants practiced the complete manufacturing process of influenza vaccines (whole and split virus).
Intravacc continues training of mainly manufacturing of developing countries, most of the time tailored to the needs of the trained institute.