Nobilon receives European GMP approval for production of Influenza vaccines for clinical trials

20-Oct-2005

Nobilon International obtained a European Good Manufacturing Practice (GMP) approval to produce human influenza vaccines for use in clinical trials. The approval was granted recently by the Dutch Ministry of Public Health following a mandatory inspection of the company's premises in Boxmeer, the Netherlands. It means that Nobilon - which was set up by Akzo Nobel in 2003 to develop and commercialize human vaccines - is now licensed to manufacture flu vaccines to be used in clinical testing, with the first trials scheduled to start in 2006.

After completing in vitro and toxicological testing, the next phase of development will be to determine the safety and efficacy of Nobilon's flu vaccine in humans. For this purpose clinical vaccine batches need to be produced under GMP. Nobilon employs a novel vaccine production system which uses large scale cell culture technology in 2000 liter fermentors, as opposed to the traditional method of using commercial embryonated chicken eggs. This advanced technology is more reliable and results in pure, safe and efficacious vaccines with constant quality. Furthermore, in the event of a pandemic bird flu outbreak, Nobilon's cell culture production can be used immediately in contrast to the traditional production system based on chicken eggs which needs a significant logistical coordination and could lead to eggs becoming unavailable.

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2 products
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