Novartis receives regulatory approval in Germany for Celtura

BASEL, Switzerland — Novartis announced Nov. 5 that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza H1N1 2009 monovalent vaccine, Celtura.

Novartis continues to pursue registration in other countries, including Japan and Switzerland.

Celtura uses a validated cell culture line for production of viral antigen components rather than traditional chicken eggs. The technology has previously been licensed in Europe for the production of the seasonal flu vaccine Optaflu.

"Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.

"We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany, to respond to the need for a pandemic vaccine. Also we are close to completion of a second cell culture-based influenza vaccine manufacturing site in the U.S., which is being built in partnership with the U.S. Department of Health and Human Services."