원문정보
초록
영어
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-HBs 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 enriched phage-display library and a Chinese hamster ovary (CHO) cell line, HB-C7A, was established which produces a fully human anti-HBs IgG1 antibody. 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 and chronic hepatitis B treatment. Phase I clinical trial of this mAb for healthy volunteers was completed without any serious adverse events and current stage is in clinical phase II/III for liver transplantation in Korea. This HB-C7A mAb has several advantages compared to plasma-derived Hepabig® such as activity, safety and availability.