BiodefenseAnthrax vaccine program demonstrates 36 month product stability
Maryland-based PharmAthene has achieved an important program milestone in its recombinant protective antigen (rPA) anthrax vaccine program, and demonstrated thirty-six month stability of its rPA drug product candidate; the data suggest that the rPA product candidate is both highly stable and potent; stability has historically been a stumbling block for other recombinant anthrax vaccine programs
Annapolis, Marlyland-based PharmAthene said it has achieved an important program milestone in its recombinant protective antigen (rPA) anthrax vaccine program and demonstrated thirty-six month stability of its rPA drug product candidate, previously produced at Avecia Biologics Laboratories in the United Kingdom. The stability data were prepared using a variety of analytical methods and a well characterized mouse challenge potency assay.
Dr. 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.
Fuerts said that the use of modern recombinant vaccine technology provided a number of distinct advantages. 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, the company has 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 rapidly to 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,” Fuerst said
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.
