From "FluWiki" today:
First vaccine factory ready for flu pandemic
http://rawstory.com/news/dpa/First_vaccine_factory_ready_for_flu_10022007.html
[FONT=Times New Roman, Times, serif]First vaccine factory ready for flu pandemic By Sandra Trauner[/FONT] [FONT=Times New Roman, Times, serif][FONT=Verdana, Arial, Helvetica, sans-serif]http://rawstory.com/[/FONT][/FONT]<TABLE cellPadding=0 width="100%" border=0><TBODY><TR><TD vAlign=center width="70%">dpa German Press Agency
[FONT=Verdana, Arial, Helvetica, sans-serif][FONT=Times New Roman, Times, serif]Published: Tuesday October 2, 2007[/FONT][/FONT]</SCRIPT><SCRIPT language=javascript src="http://www.netscape.com/lib/js/handlers.js" type=text/javascript></SCRIPT></TD><TD vAlign=center width="30%"><TABLE cellSpacing=0 cellPadding=2 width="100%" border=0><TBODY><TR><TD><SCRIPT>reddit_url=window.location.href</SCRIPT><SCRIPT>reddit_title='First vaccine factory ready for flu pandemic By Sandra Trauner'</SCRIPT><SCRIPT language=javascript src="http://reddit.com/button.js?t=2"></SCRIPT></TD><TD><SCRIPT src="http://digg.com/tools/diggthis.js" type=text/javascript></SCRIPT></TD></TR></TBODY></TABLE>
Marburg, Germany- 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 immunize 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 (85-
million-dollar) 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.
? 2006 - dpa German Press Agency
First vaccine factory ready for flu pandemic
http://rawstory.com/news/dpa/First_vaccine_factory_ready_for_flu_10022007.html
[FONT=Times New Roman, Times, serif]First vaccine factory ready for flu pandemic By Sandra Trauner[/FONT] [FONT=Times New Roman, Times, serif][FONT=Verdana, Arial, Helvetica, sans-serif]http://rawstory.com/[/FONT][/FONT]<TABLE cellPadding=0 width="100%" border=0><TBODY><TR><TD vAlign=center width="70%">dpa German Press Agency
[FONT=Verdana, Arial, Helvetica, sans-serif][FONT=Times New Roman, Times, serif]Published: Tuesday October 2, 2007[/FONT][/FONT]</SCRIPT><SCRIPT language=javascript src="http://www.netscape.com/lib/js/handlers.js" type=text/javascript></SCRIPT></TD><TD vAlign=center width="30%"><TABLE cellSpacing=0 cellPadding=2 width="100%" border=0><TBODY><TR><TD><SCRIPT>reddit_url=window.location.href</SCRIPT><SCRIPT>reddit_title='First vaccine factory ready for flu pandemic By Sandra Trauner'</SCRIPT><SCRIPT language=javascript src="http://reddit.com/button.js?t=2"></SCRIPT></TD><TD><SCRIPT src="http://digg.com/tools/diggthis.js" type=text/javascript></SCRIPT></TD></TR></TBODY></TABLE>
</TD></TR></TBODY></TABLE>By Sandra Trauner, Marburg, Germany- 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 immunize 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 (85-
million-dollar) 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.
? 2006 - dpa German Press Agency