Since the development of low serum/serum-free culture technology, human serum albumin has been widely used in the research and application of replacing serum. The main functions of human serum albumin in cell culture are as follows:
1. Maintain the osmotic pressure and pH of the cell culture medium system;
2. As a carrier to combine and transport the lipids、metal ions、amino acids and other important ligands;
3, Act as an antioxidant.
A large number of studies have shown that adding human serum albumin to the serum-free medium can achieve stable cell growth, and even achieve synergistic growth after gradual acclimation and adaptation of cells, and can perform synergistically with other growth factors to promote cell growth and improve cell productivity.
However, the commercially available human serum albumin is extracted and purified from human blood, which may contain viruses or prions, and has risks of infections HIV or liver disease. In addition, the human serum albumin is in short supply in clinical drug. Now only 1/4 of annual demand is produced domestically; one-half depends on imports; there is still a shortage of 1/4. In recent years, the blood supply is getting tighter and tighter. In the case of shortage of clinical drug, the production capacity of human serum albumin is becoming more and more difficult to meet the bulk production supply of life science and biopharmaceutical raw materials.
Since the 1990s，human serum albumin has become a national strategic project. Wuhan Healthgen Biotechnology Corp. (hereinafter referred to as Healthgen Biotech) based on the rice endosperm cell expression technology platform to produce recombinant human serum albumin (OsrHSA). Compared with plasma-derived human serum albumin, OsrHSA has no animal-derived components and no risk of viral infections, which also reach super bulk capacity through large-scale rice planting expansion. The OsrHSA was approved for clinical trials in China and the US in 2017 and 2019, respectively, and finished phase I from US FDA. The OsrHSA is the first innovative drug produced based on rice endosperm cell bioreactor in China and even in the world.
Except in the clinical drug market , Healthgen Biotech also developed different grades recombinant human serum albumin, such as cell culture grade. Healthgen Biotechdedicated to biopharmaceutical, cell therapy and other biological medical industry raw materials, to help to improve product production process, improve safety and control system. In addition, the OsrHSA has been achieved an annual ton metric supply. The facility has gained the ISO certificate, complies with GMP.