Friday, 24 February 2012 10:00

Allergan: Cell-based in vitro-assay for Botox products in Germany and Europe Featured

The German Federal Institute of Drugs and Medical Devices (BfArM) has approved an animal-free procedure for testing of Allergan´s botulinum products.

With this method on the basis of cell cultures animals are no longer nessessary. The in vitro test has been developed by Allergan and should be the first one which got an approval for testing of currently avialable botulinum toxins (InVitroJobs reported about the development several times, see here and here). According to the manufactorer after more than ten years of development by Allergan, for which a financial effort of US$ 65 million had been nessessary, the new in vitro method should be used as quick as possible in the botulinum production for distribution in Germany.

The approval of BfArM is exclusively restricted to botulinum products of Allergan and does not apply to other botulinum toxins of other manufactorers.

More information (in german):
http://www.presseportal.de/