Abstract
Diphtheria toxin inactivated by formaldehyde is known as diphtheria toxoid and is used as a vaccine component. Formaldehyde-treated toxins are heterogeneous with respect to size, charge and chemistry. To assess the comparability of 14 experimental and routine diphtheria toxoid production batches, capillary electrophoresis, biosensor analysis, denaturation studies (monitored by fluorescence spectroscopy) and free amino group analysis were performed in addition to routine potency and toxicity tests. Capillary electrophoresis revealed differences in size distribution. Up to threefold differences in the degree of binding to an anti-diphtheria toxin antibody were observed by biosensor analysis. The denaturation studies indicated variation in conformatioal stability, which seemed to be inversely correlated with the number of residual free amino groups. The overall results show batch-to-batch variations and indicate that these techniques are useful in the quality control of diphtheria toxoid batches.
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