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Wave Biotech Announces Strategic Alliance on Pandemic Influenza
Vaccine Production Technologies

Wave Biotech, LLC, has announced today that the company is working
with a number of worldwide pharmaceutical and biotech manufacturers
that are making vaccines in the disposable Wave Bioreactor(R). In
its latest collaboration effort, Wave Biotech has entered into an
agreement with Novavax, Inc. (Nasdaq: NVAX), based in Malvern, PA,
and both companies will jointly collaborate on the development of a
commercial scale production process for Novavax's pandemic influenza
virus (avian flu) vaccine and other biological products. Wave
Biotech will provide process and equipment expertise for the
propriety technology based on disposable equipment for the
manufacture of biologicals. The initial focus of the collaboration
will be on Novavax's H5N1 avian-flu-Like Particle (VLP) vaccine. The
joint collaboration will demonstrate in a production process that
can express potent vaccine at high yield at the 500-liter scale.

Vijay Singh, President and founder of Wave Biotech, LLC, issued the
following statement: "Wave Biotech's disposable cell culture
technology is an ideal fit for the Novavax application because it
provides scalable technology that can be delivered, installed, and
commissioned quickly for possible worldwide use."

Non Traditional Approach May Prove Necessary in the Race Against
Time Wave Biotech first began development on their innovative
technology for the bioreactor six years ago, which may prove to be a
critical component in the race to develop vaccines before a flu
pandemic has an opportunity to occur. The company offers a quick way
to rapidly manufacture and deploy
bioreactors of up to 500 liters operating volume. Using large
plastic bags as
cell culture vessels, the bags are inflated, filled with culture
nutrients,
and inoculated with the cells of choice. These bags are placed on
special
machines that rock in a back and forth motion, generating waves that
effectively aerate and mix the contents, thus producing a highly
effective
environment for cell growth and productivity. The machines have been
fully
operational since 1999, and are currently in use at almost every
pharmaceutical or biotech company worldwide. They have been licensed
as part
of processes to produce human therapeutics and are built to comply
with all
applicable FDA guidelines. Most critically, they have a proven track
record
with many cell lines and viruses having been used for the production
of
proteins, viruses, gene therapy products, and vaccines. Due to the
inexpensive
and simple pre-sterilized disposable culture bag, cell culture can
be carried
out by low-tech labor without the need for extensive plant
infrastructure. The
rocking machines are mass-produced and can be delivered in weeks as
compared
to six months or longer for traditional stirred tank bioreactors.
Dr. Singh acknowledged that current issues concerning the
possibility of
an influenza pandemic striking humanity in the very near future is
based on
several notable factors. "First of all, the influenza virus is
capable of
mutating rapidly so that most people would have no significant
resistance and
would succumb. Additionally there is a disturbing increase in the
occurrence
of avian flu in Asia as well as the latest evidence in some of the
eastern
European countries. It is clear that the great influenza epidemic of
1918 was
avian origin, followed by others in 1957 and 1968," he
said. "Statistically,"
he continued, "another appears to be due at this time." He also
noted that
there are now anti-viral pharmaceuticals that may be useful in
treating those
people infected by the influenza virus, but he cautioned that the
efficacy and
availability of such drugs are very limited.
"The problem with influenza vaccines is that the virus mutates
rapidly and
a vaccine made against one strain will likely be useless against
another one,"
said Singh. "Making such a vaccine is very time consuming and takes
eight to
ten months to build up a significant stockpile of doses."
The manufacturing equipment developed by Wave Biotech can be
quickly
configured and deployed anywhere in the world within days. The cells
only
contact a single-use bag and these bags can be stockpiled for up to
three
years providing an option for almost instant vaccine manufacturing.
The
equipment has been optimized over several years to enable easy
operation with
minimal training required. This method would enable vaccine
facilities to be
rapidly established anywhere in the world to combat the disease at
the local
level, thus preventing its release into the general population. The
disposable
cell culture bags can be manufactured in large quantities in simple
factories
using heat seaming equipment, delivered pre-sterilized by radiation
and ready
for use.

Engineered Baculovirus
Current vaccine manufacturers use 1950's chicken egg technology
and other
methods to make the vaccine. Singh considers these methods far more
primitive
because "even 350 million chicken eggs would only yield 300 million
doses
which would take at least six months to develop." Dr. Singh
added, "This
technology is not likely to save a significant number of people since
compounding the problem is that if, indeed, the flu is avian origin,
then
where are the significantly large numbers of eggs needed to make the
vaccine
going to originate? The Spanish Flu epidemic of 1918 is estimated to
have
killed between 50 and 100 million people, at a time when world
population was
only 1.8 billion. Today we have 6.5 billion people and the impact of
a virus
such as the one in 1918 would clearly prove to be even more
devastating."
Singh claims it is both necessary and critical for governments
worldwide
to secure alternative technologies to rapidly make an engineered
cell line for
vaccine production.
"One approach, developed by Novavax, is to identify the gene
sequences of
the virus as it exists now in the Far East and rapidly clone into
baculovirus," said Dr. Singh. "This engineered baculovirus can be
used to
infect insect cells grown in liquid culture media and rapidly
express large
amounts of a suitable vaccine. This approach has been tested, proven
and
requires simple culture media that can be made from common
chemicals. This
way, it is possible to clone and develop a cell expressions system
against a
specific influenza strain within six weeks of securing the sample.
While
getting a cell line that produces the desired vaccine is only part
of the
story, in order to make sufficient quantities of the vaccine in such
a time-
sensitive manner, it will be essential to grow large numbers of
cells using
thousands of liters of cell culture capability."

About Wave Biotech
Wave Biotech is a research-based company that develops and
manufactures
innovative process equipment for the pharmaceutical and biotechnology
industries. The Company's focus is on developing disposable
bioprocess
equipment for the operation traditionally requiring stainless-steel
tanks and
piping. Key products, such as the Wave Bioreactor(R), WaveMixer(R),
FlexMixer(R), and Sterile Tube Fuser, feature disposable contact
materials
that eliminate cleaning and validation, thereby reducing costs in
operations
ranging from cell culture, media preparation, and buffer dissolution
and
thawing process intermediates to patient specific cell therapy in
hospitals.
These unique, patented, devices can be installed and commissioned
rapidly,
thereby drastically reducing the time-to-market for biological
products. Wave
Biotech's equipment is in use with hundreds of companies worldwide,
both for
R&D, as well as commercial applications.

SOURCE Wave Biotech, LLC

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