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

Nobilon International has obtained a European 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, Netherlands.

As a result Nobilon - which was set up by Akzo Nobel in 2003 to develop and commercialise human vaccines - is now licensed to manufacture flu vaccines to be used in clinical testing, with the first trials scheduled to start in 2006.

Nobilon employs a novel vaccine production system that uses large-scale cell culture technology in 2000-litre fermentors, as opposed to the traditional method of using commercial embryonated chicken eggs. This technology is said to be more reliable and to result 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 co-ordination and could lead to eggs becoming unavailable.

'This approval represents a significant step forward in the development of our cell-based inactivated influenza vaccine,' said Nobilon Director Dr Adriaan van Loon. 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.