Big news for NVAX
Wave Biotech Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies
SOMERSET, N.J., Oct. 17 /PRNewswire/ -- 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
--------------------------------------------------------------------------------
Issuers of news releases and not PR Newswire are solely responsible for the accuracy of the content.
Terms and conditions, including restrictions on redistribution, apply.
Copyright © 1996-2005 PR Newswire Association LLC. All Rights Reserved.
A United Business Media company. |
