A study of the physiology of Bacillus anthracis Sterne during manufacture of the UK acellular anthrax vaccine
A study of the physiology of Bacillus anthracis Sterne during manufacture of the UK acellular anthrax vaccine
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DOI：
10.1111/j.1365-2672.2007.03391.x
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发表时间：
2007-11-01
影响因子：
4
通讯作者：
Hallis., B.
中科院分区：
文献类型：
--
作者：
Charlton, S.;Herbert, M.;Hallis., B.
目的：分析模拟英国炭疽疫苗生产过程中炭疽杆菌的生长情况。方法和结果：使用B的致突变无囊Sterne 34 F（2）菌株进行模拟疫苗生产运行。炭疽菌在半确定培养基中。在对数生长期，培养物的pH值上升后，在约18 h开始下降，从pH 8中心点7下降到26 h < 7中心点6，这与葡萄糖消耗和保护性抗原的最佳产生相一致（PA; 7中心点89 μ g/ml）1，SD 1中心点0）和致死因子（LF; 1中心点85 μ g/ml）1，SD 0中心点29）。在26 - 32小时期间，没有观察到毒素抗原的分解增加。当葡萄糖耗尽时，氨基酸（主要是丝氨酸）被用作替代碳源。在32 h内未观察到孢子形成。结论：PA和LF是英国炭疽疫苗的主要成分，在疫苗发酵过程中几乎没有降解。疫苗生产工艺具有耐用性和重现性。这项研究的意义和影响：这是对英国无细胞炭疽疫苗生产工艺的首次详细分析;对该工艺的深入了解将支持持续和安全的疫苗生产。
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 semidefined medium. After rising during the logarithmic growth phase, the pH of the culture starts to fall at about 18 h from pH 8 center dot 7 to reach < 7 center dot 6 at 26 h, coincident with consumption of glucose and optimal production of protective antigen ( PA; 7 center dot 89 g ml) 1, SD 1 center dot 0) and lethal factor ( LF; 1 center dot 85 g ml) 1, SD 0 center dot 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.