Approximately 100,000 doses can be manufactured per week
MERIDEN, Conn., June 15 /PRNewswire/ — Protein Sciences Corporation (PSC) announced that today it commenced manufacturing of a vaccine to protect humans against the H1N1 “swine flu” virus. The Company estimates that it can produce 100,000 doses this week and at least 100,000 doses per week thereafter. The vaccine, called PanBlok(R), is made using PSC’s proprietary baculovirus and insect cell manufacturing technology. PSC believes that PanBlok is the first and only vaccine that could be used to protect against the escalating worldwide pandemic, at least for the next few months.
Following bulk production, the vaccine will undergo routine quality tests, the longest of which will require up to one month. Thus, by mid-July the vaccine should be ready to be used in clinical trials and/or for vaccinations in countries that grant regulatory clearance.
Daniel D. Adams, Chairman, President and CEO stated, “We are in the process of transferring our proprietary manufacturing technology to facilities in other countries and we are setting up a foundation to ensure vaccine availability for U.N. member countries consistent with the commitment we made to the World Health Organization and the United Nations in Geneva, Switzerland on May 19, 2009.” He added, “Using our proprietary technology, licensees could be producing vaccine in as little as two to three weeks if they are currently working with insect cells and in a few months if they are now producing monoclonal antibodies.”
PSC is in late stage discussions with various parties in the United States and abroad to conduct the first human clinical trials of an H1N1 vaccine. Such studies will evaluate different doses, two dosing regimes and an adjuvanted formulation of the vaccine.
PSC is a privately held biopharmaceutical company based in Meriden, Connecticut, whose mission it is to save lives and improve health, by effectively responding to our changing world with innovative vaccines and biopharmaceuticals. PSC uses recombinant DNA technology to make novel human and veterinary prophylactic and therapeutic vaccines and diagnostics. The active ingredients in all of the firm’s products are recombinant proteins that are manufactured, using its patented protein expression technology, based upon baculovirus and insect cell technology.
PSC’s lead product is FluBlok(R), a seasonal recombinant trivalent influenza vaccine consisting of influenza hemagglutinin proteins. FluBlok is manufactured without the use of eggs, is highly purified and, therefore, does not require the use of thimerosal or antibiotics, and is low in endotoxins. PSC filed a Biologics License Application for FluBlok with the FDA in April 2008 that is currently undergoing final review. PSC anticipates that FluBlok will receive FDA approval in time for the 2009/2010 influenza season.
Source: PEC Press Release: www.proteinsciences.com