Dr. Fuerst's presentation also highlighted the important technical milestones that PharmAthene achieved for its SparVax™ program during 2011. These include completing technology transfer of the manufacturing process and cGMP manufacturing of the final drug product at full commercial scale. SparVax™ also demonstrated 36 months of final drug product stability, a particularly noteworthy achievement, as stability has historically been a stumbling block for other rPA vaccine programs. PharmAthene also increased rPA yield six-fold at the bulk drug substance stage, which is highly significant in terms of being able to fill government stockpile requirements.
PharmAthene's rPA anthrax vaccine program has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority.
SparVax™ is a novel second generation anthrax vaccine being developed to protect against inhalation anthrax, the most lethal form of anthrax infection in humans. The vaccine contains highly purified recombinant protective antigen (rPA) and has been shown to stimulate protection against anthrax by eliciting a specific immune response to one of the primary proteins excreted by the Bacillus anthracis organism. Unlike the first generation anthrax vaccine and other rPA-based anthrax vaccines in development, SparVax™ is produced using E. coli, which enables a much more robust and scalable manufacturing process. In addition, SparVax™ is capable of being produced at greater than 150 million rPA vaccine equivalent doses per year (at 50 mcg per dose) using a single 1,500-liter fermentor. The unique manufacturing process also mitigates the detrimental effect of proteases. SparVax™ is expected to undergo additional Phase II clinic
|SOURCE PharmAthene, Inc.|
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