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Equal Allergenic Potency of Beta-Lactam Antibiotics Produced by Chemical or Enzymatic Manufacturing – Mouse IgE Test

Background: Cephalexin and amoxicillin are semisynthetic β-lactam antibiotics with a broad spectrum of antibacterial activity against gram-positive and gram-negative microorganisms. Both antibiotics are produced by a new ‘green’ process in which enzyme technology is used to combine the intermediate structure and the side chain in an aqueous medium to yield cephalexin or amoxicillin, thus avoiding the use of several chemical reagents and volatile organic solvents. As a result of the enzyme technology a new residual protein impurity has been identified. To check for the sensitizing capacity of the residual protein, a mouse IgE test was used to detect differences in the production of specific IgE by chemical or enzymatic preparations of the antibiotics. Methods: Balb/c female mice were immunized intraperitoneally with alum and conjugates of different amoxicillins or cephalexins with ovalbumin (OVA). After 16 days, the amoxicillin mice were injected with one half the original amount of antigen. After 19–23 days, the sera were tested for specific IgE by the passive cutaneous anaphylaxis assay in Sprague-Dawley rats. The greatest dilution of sera which resulted in a positive response was the titer of specific IgE. Results: No significant differences were found between the titers of specific IgE caused by the chemically and enzymatically produced β-lactam antibiotics, indicating that the antibiotics are equal in allergenicity. Conclusions: The data show that a residual level of 35 ppm protein did not affect the allergenic potency of these β-lactam antibiotics as determined by the mouse allergenicity model.