Abstract
This study aimed at process development and pilot-scale production of botulinum antitoxin for an urgent botulism-poisoning patient, contributing to steady antitoxin supply for bio-terrorism. After horses were immunized with formalin-inactivated botulinum toxin type A and B, the sera were prepared. Following purifications of IgG fractions by cold ethanol fractionation, caprylate fractionation, anion and exchange chromatography, and F(ab′)2 by cold ethanol fractionation, pepsin digestion, and cation exchange chromatography, the specificity and protective efficacy against botulinum toxin type A and B were analyzed by enzyme-linked immunosorbent assay (ELISA), Western blot, and mouse neutralization assay. Based on the result of mouse neutralization assay, it was found that 25 μg of anti-type A IgG and 350 μg of anti-type B IgG were equal to 1 IU. Neutralizing potency of F(ab′)2 was also analyzed as 30 and 350 μg/IU for type A and B toxins, respectively, showing that the neutralizing activity of the F(ab′)2 is close to that of IgGs. In this report, we successfully established the manufacturing process of equine botulinum toxin type A and B antitoxin and produced freeze-dried prototype products.
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