Development of an in Vitro-Based Potency Assay for Anthrax Vaccine
ARMY MEDICAL RESEARCH INST OF INFECTIOUS DISEASES FORT DETRICK MD
Pagination or Media Count:
The potency assay currently used to evaluate consistency of manufacture for the anthrax vaccine is contingent upon meeting specified parameters after statistical analysis of the percent survival and time to death of vaccinated guinea pigs after challenge with spores of a virulent strain of Bacillus anthracis. During the development of a new anthrax vaccine based upon recombinant protective antigen rPA adsorbed to aluminum hydroxide gel Alhydrogel, we found that the serological response of female AJ mice, as measured by a quantitative anti-rPA IgG ELISA, may be an effective method to monitor a manufacturers consistency for rPA-based vaccines. An advantage of the proposed in vitro-based potency assay is that it will not need stringent biosafety containment measures as required by the current guinea pig potency assay.
- Anatomy and Physiology