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| The Progress of Therapeutic Antibody Drug and the Industrial Key-technology of Antibody Production |
| LIU Bo-ning |
| New Drug Reaserch and Development Center, North China Pharmaceutical Group Corporation and State Key Laboratory of Antibody Drug Reaserch and Development, Shijiazhuang 050015, China |
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Abstract The development of therapeutic antibody technology has experienced with three stage including polyclonal antibody from antiserum, monoclonal antibody from hybridoma, and the recombinant antibody technology. Moreover, the recombinant antibody technology ensures therapeutic antibody possible to commercial manufacturing. Owing to lower immunogenicity and higher clinic efficacy, the humanized and full human antibodies have been dominant in approved antibody drug, instead of mouse or chimeric antibodies. With successes in the cancer and autoimmunity therapy, the antibody industry has become primary component pharmaceutical in the world. According to the industry capacity and launched antibody products, the China antibody industry was in initial stage. Further, the technology bottleneck limiting antibody drug industrialization was identified, which involved with establishment of antibody-producing cell line, process development of large scale cell culture, and purify and quality control of antibody product. The development of industrial key-technology, mentioned above, will accelerate the process of antibody industry in china.
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Received: 11 January 2013
Published: 25 May 2013
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