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July 12, 2011 /PRNewswire/ -- PharmAthene, Inc. (NYSE Amex: PIP) announced today that it has achieved an important program milestone in its recombinant protective antigen (rPA) anthrax vaccine program and demonstrated 36 month stability of its rPA drug product candidate previously produced at Avecia Biologics Laboratories in the
United Kingdom. The stability data were prepared utilizing a variety of analytical methods and a well characterized mouse challenge potency assay.
Thomas Fuerst, Executive Vice President and Chief Scientific Officer, remarked, "Demonstration of 36 month final product stability is considered an important technical milestone under our current contract with the Biomedical Advanced Research and Development Authority (BARDA). We are extremely pleased to announce this achievement, which suggests that our rPA product candidate is both highly stable and potent. Stability has historically been a stumbling block for other recombinant anthrax vaccine programs, so we're especially excited about these ongoing results, which represent an important breakthrough for PharmAthene's rPA vaccine program.
In addition, our process sciences team has made excellent progress optimizing the fermentation process and successfully demonstrated a 6-fold increase in rPA yield at the bulk drug substance stage, which is significant. Our robust manufacturing platform, which utilizes
E. coli rather than
B. anthracis, enables significantly enhanced rPA production yield without production of destructive proteases, a key differentiating feature between PharmAthene and other rPA programs."
"The use of modern recombinant vaccine technology provides a number of distinct advantages," continued Dr. Fuerst. "First, the engineered cells produce only the protective antigen (PA) component of the anthrax toxin, resulting potentially in a more consistent vaccine. The enhanced consistency and purity of rPA-based vaccines may reduce the likelihood of side effects and adverse reactions. Additionally, we have established a manufacturing process whereby inclusion bodies (an intermediate step in the process) can be frozen and stored for surge capacity. Finally, recombinant technology employing modern, industrial biotechnology manufacturing processes, provides the flexibility to rapidly scale up production in the event of a national emergency. These advantages should translate to a much more cost effective vaccine for the U.S. government and its citizens. Modern commercial recombinant vaccines have proven highly effective against several important diseases, including hepatitis and human papillomavirus infections, and we look forward to continuing to advance our rPA anthrax vaccine towards commercialization in order to better protect Americans both at home and on the battlefield."