First vaccine factory ready for flu pandemic 02/10/2007 00:00

2 October 2007

Marburg, Germany (dpa) - A new type of factory that speeds up production of influenza vaccine was completed Tuesday in Germany as the world prepares to cope with a pandemic that might kill hundreds of millions of people.

The cell-culture-derived vaccine from the plant, built by Switzerland's Novartis AG at Marburg, Germany, is manufactured without using eggs, the usual medium for mass-producing flu vaccine.

Instead, cells that derive from a long-dead and nameless dog will be used. US scientists isolated the cells about 50 years ago from the kidney of a cocker spaniel and have been been reproducing them ever since. They are ideal as a host for influenza viruses.

The killed virus is injected to immunise people against the currently prevalent strains of influenza.

The new technology offers an alternative to propagating the virus in millions of eggs from domestic fowls.

Chancellor Angela Merkel, a former research physicist, headed up the VIP guest list for the inauguration of the 60-million-euro plant in Novartis Behring's existing vaccines complex.

The new product, Optaflu, won European Union regulatory approval in June.

Novartis is also building a cell-culture-derived influenza vaccines plant in Holly Springs, North Carolina.

Switching on a small green light was symbolic for the launch of a complex manufacturing process and the training of 150 new staff.

During the inauguration, the VIPs were allowed into the clean room in regular clothes. Later, the four-storey building will be closed to anyone who is not wearing special hygienic clothing.

The manufacturing process begins in the top storey where the cell culture from the cocker spaniel is propagated in three fermenters.

One storey below, the cells are infected with the flu virus, then descend a level for the virus to be inactivated. On the lowest level, the product is refined.

Starting from one millilitre of nutrient, the substances are passed through vats, pipes, centrifuges and instruments, growing in volume to thousands of litres and emerging 30 days later as 10 litres of pure antigen.

This contains virus components that prompt an immune reaction in humans without causing actual influenza symptoms.

Markus Leyck Dieken, chief executive of Novartis Behring, compared the various strains of live virus to demanding guests in a hotel. Flu jabs must be altered every year to match the world's mutating viruses.

"Every year we get new guests in the hotel," he said. "One demands an extra blanket, another requires fresh air in the room and a third only wants to eat organic." Making each flu virus comfortable to its own taste is the key to cultivating it.

"The virus does not grow any faster in cell culture than in chicken eggs," said Leyck Dieken, "but the growing medium is there whenever you need it, so the start-up time is shorter."

The new process could be crucial if a pandemic breaks out, said Susanne Stoecker, spokeswoman for the Paul Ehrlich Institute, the German government agency that approves new vaccines.

"If H5N1 bird flu virus mutated into a form that was infectious among humans, we would have a huge problem if the virus had previously wiped out all our poultry, since the eggs we need would be in short supply," she said.

Novartis Behring says its Optaflu process has other benefits as well.

"A closed reactor system is less at risk of contamination than a biological product like an egg," explained Leyck Dieken. "Every egg has to be handled by a worker, and the eggs all have holes in them."

Novartis says the vaccine strain in mammalian cells may also better match the original "wild" virus than in egg cells.

No date has been set for the first batch of cell-derived vaccine to be completed. The company has yet to receive regulatory approval for a current-season version of Optaflu, but Novartis hopes to ship doses before the year is out.

By 2009 it aims to boost its flu vaccine production for Europe at Marburg from 8 million seasonal doses currently to 40 million annually. The US Optaflu plant would have annual production capacity of up to 50 million doses, earlier Novartis announcements have said.

DPA

Subject: German news