Wave Biotech Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies

Oct 17, 2005, 01:00 ET from Wave Biotech, LLC

    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