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After 30 years of development, therapy with monoclonal antibodies has started to realize its promise. Therapeutic antibodies represent one of the fastest growing areas of the pharmaceutical industry. There are currently 20 monoclonal antibodies in the market
that have been approved by the FDA and over 150 in clinical developments.
Monoclonal antibodies may have a number of promising potential therapeutic applications in the treatment of cancer, autoimmune diseases, viral infections, asthma, and other diseases.
Hepatitis B virus (HBV) is one of the main pathogens of hepatitis and hepatocarcinoma.
Human plasma-derived Hepatitis B immune globulin (HBIG) is being used for prophylactic and liver transplantation currently. However, it is required to replace a HBIG with a recombinant one because of limited availability of human plasma with high anti-HBV antibody titer and possible contamination of human pathogens. In order to meet this requirements, we selected human antibody to the HBsAg from an anti-HBs Ab-enriched phage-display library and a Chinese hamster ovary (CHO) cell line, HBC7A, was established which produces a fully human IgG1 antibody against HBV. Mass production and purification processes were established and this mAb was characterized in terms of HBV neutralization and safety for the purpose of human trial for liver transplantation.