Therapeutic human serum albumin (HSA) is primarily derived from donated human blood, which is mainly used in the treatment of liver cirrhosis, hemorrhage shock, severe burn, scald, plastic surgery, hypoproteinemia, renal edema etc. Currently, the demand of HSA is about 850 tons per year worldwide, and 420 tons per year in China. In recent years, due to shortage of blood plasma, HSA supply is shortage, particular in China and Asian countries, 60% HSA demand depend on the imports in China. Simultaneously, the threat of blood-borne diseases such as AIDS and hepatitis has become the more and more concerns. So, FDA and EMEA explicitly encourage the application of the recombinant HSA with animal component free.
Given its high demand, scientists had been attempting to use recombinant technology for decades to produce recombinant HSA in various organisms such as bacteria, yeast, tobacco and even cows. However, it had been difficult to produce cost-effective and non-immunogenic HSA suitable for large dosages used in treatments. Thus far, there had been no attempts on human trials with recombinant HSA. Dr. Daichang Yang, professor of Wuhan University and president of Healthgen Biotech with his colleagues established a rice endosperm specific expression technical platform-OryzHiExp to highly express recombinant HSA. After more than decade efforts, the excipient grade recombinant human serum albumin(OsrHSA) derived from rice has successfully obtained the Drug Master Files (DMF) number(No. 029648) from US Food and Drug Administration (FDA) in 2015, which showed that the excipient grade OsrHSA has good safety and the rice expression platform has been highly approved by FDA and the international market.
|Amino Acids Sequence||Same||Same|
|Thermal Stability||M/P 65℃||M/P 65℃|
The OsrHSA is animal component free and has very good batch consistency, which can be widely used in cell and gene therapy, vaccine manufacture and formulation, bio-pharmaceutical production and formulation, cryopreservation of cell, medical devices. The OsrHSA has two different grades, excipient grade and cell culture grade.