Akinori Sumi

Purification of Recombinant Human Serum Albumin Efficient purification using STREAMLINE

Two inter-related challenges must be overcome to develop a recombinant human serum albumin process. One is purity; the other is cost. Regarding cost, our goal is to produce recombinant human serum albumin at least as economically as plasma derived human serum albumin. To control production costs, maximum quantities of albumin must be produced from minimum volumes of cell culture, followed by high efficiency, high-yield purification methods. By introducing STREAMLINE technology, we have improved productivity by roughly 50% in terms of processing time and 45% in terms of yield. Furthermore, the life time of the gel and column are very long. After more than 1000 process cycles, performance remained unchanged.

Properties of recombinant hepatitis B vaccine

A large-scale purification method for hepatitis B surface antigen produced in a recombinant yeast (Saccharomyces cerevisiae) was established. The resulting HBsAg was greater than 99% pure and suitable for vaccine use. The yeast-derived HBsAg was structurally and biochemically similar to plasma-derived HBsAg. The anti-HBs antibody producing potency of the yeast-derived vaccine in mice was significantly higher than that of the plasma-derived vaccine. The yeast-derived vaccine induced protective antibody against hepatitis B virus of either adr or ayw subtype in a chimpanzee efficacy study. These observations demonstrate the usefulness of the yeast-derived vaccine as a second-generation hepatitis B vaccine.