Establishment of a mass production system of human monoclonal anti-toxin antibodies

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In 1999, Japanese and Chinese researchers had three meetings and agreed that the production of human monoclonal antitoxins would be performed in Lanzhou Institute of Biological Product and that Japanese researchers would support the production by laboratory examination of culture conditions. Because of the delay in adaptation of hybridomas for the production of human anti-tetanus monoclonal antibodies, we focused our effort on the mass culture of the hybridomas in the medium containing 5 % FCS and the way of purification of antibodies from the culture. Perfusion culture of the hybridomas for 1.5 months gave us 1.5 g of IgG in total, and the concentration of the antibodies in the culture was 7X10^<-3> IU/ml. The most effective way of purification was proved to be a combination of an affinity chromatography with tetanus toxoid and an ion-exchange chromatography with Mono Q column. Neutralizing activities of final preparations of G2 and G6 were 6.2 IU and 20.4 IU for 100 μg IgG, respectively. Characteristics of these preparations as biological products are now under investigation in National Institute for the Control of Pharmaceuticals and Biological Products in China.