Long-term physicochemical and immunological stability of a liquid formulated intact ovine immunoglobulin-based antivenom

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Abstract

An antivenom should be stable under the conditions that it will be both transferred and stored. Thus instability may lead to a loss of efficacy and an increased incidence and severity of adverse effects. Stability is a particular problem in countries where the temperatures and humidity are high. Here we investigate the stability of a liquid-formulated, intact ovine immunoglobulin-based antivenom, EchiTAbG™, which is used extensively in Nigeria to treat envenoming by the West African saw-scaled viper, Echis ocellatus. Ampoules of antivenom were assessed as to their specific antibody content by small scale affinity chromatography and their purity by size exclusion gel filtration and turbidity. Three different batches of the antivenom revealed no significant changes, using these assessment techniques, during 42 months storage at 4 °C or at ambient temperature, followed by one month at 37 °C. These real-time studies indicate that the antivenom remains stable for a minimum of 3.5 years and that it can be exposed to tropical temperatures without any loss in immunoglobulin binding activity. This further highlights the clinical utility of liquid formulated ovine IgG antivenoms by demonstrating their retention of potency in the event of a short term failing in the cold chain.

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