A study of the physiology of Bacillus anthracis Sterne during manufacture of the UK acellular anthrax vaccine |
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Authors: | Charlton S Herbert M McGlashan J King A Jones P West K Roberts A Silman N Marks T Hudson M Hallis B |
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Institution: | Health Protection Agency, Centre for Emergency Preparedness and Response, Porton Down, Salisbury, UK. sue.charlton@hpa.org.uk |
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Abstract: | AIM: To analyse the growth of Bacillus anthracis during simulations of the UK anthrax vaccine manufacturing process. METHODS AND RESULTS: Simulated vaccine production runs were performed using the toxigenic, acapsulate Sterne 34F(2) strain of B. anthracis in semi-defined medium. After rising during the logarithmic growth phase, the pH of the culture starts to fall at about 18 h from pH 8.7 to reach <7.6 at 26 h, coincident with consumption of glucose and optimal production of protective antigen (PA; 7.89 g ml(-1), SD 1.0) and lethal factor (LF; 1.85 g ml(-1), SD 0.29). No increased breakdown of toxin antigens was seen over the 26-32 h period. When glucose was exhausted, amino acids (principally serine) were utilized as an alternative carbon source. Sporulation was not observed during the 32 h. CONCLUSIONS: PA and LF, the principal constituents in the UK anthrax vaccine, undergo little degradation during vaccine fermentation. The vaccine manufacturing process is robust and reproducible. SIGNIFICANCE AND IMPACT OF THE STUDY: This is the first detailed analysis of the manufacturing process used for the UK acellular anthrax vaccine; insight gained into the process will support continued and safe vaccine manufacture. |
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Keywords: | Anthrax lethal factor physiology protective antigen toxin vaccine |
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