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Pioneer of the world – botanical recombinant HSA enters clinical trials
Author:Wang Song  Date:2017-06-06  Clicks:

The first international recombinant human serum albumin (HSA) injection based on the production of rice endosperm cell bioreactors has recently been approved for human clinical research. The drug was developed by team led by Professor Yang Daichang from the School of Life Sciences of Wuhan University.

Human serum albumin is of extensive use in clinical treatment in China. As a plasma expander, it works well in the treatment of liver cirrhosis, burns and scalds, shock caused by excessive bleeding, brain edema, cancer and the adjuvant therapy of the chemotherapy and radiotherapy for AIDS patients and etc. In addition, it is widely used in vaccine excipients, protein drug protectants and additives for animal cells and stem cell cultivation. Human serum albumin is completely extracted from the blood plasma, with the annual demand estimated at around 420 tons per year. China is confronted with deficiency of human serum albumin with 60% reliance on imports due to the shortage of plasma. In the hospital, it is "a drug hard to find." Recent years have witness the increasingly tough threat of blood-borne diseases such as AIDS and hepatitis. Therefore, the use of non-animal sources of recombinant human serum albumin are explicitly encouraged by the United States and the European drug regulatory agencies.

Since 1986, internationally, human have attempted to replace plasma sources by producing human serum albumin with DNA technology, but no breakthrough has been achieved. The team led by Yang Daichang, after 12 years of research, has overcome several key technological difficulties like the low expression, complex purification process, large scale and detection on residual host protein and nucleic acid and so on. The quality indices reached or exceeded the standard set by "Chinese Pharmacopoeia" in 2015. According to the preclinical data, this research outcome is consistent with the commercial human serum albumin in terms of the efficacy pharmacology, pharmacokinetics and toxic toxicities. Also, the immunological indices show that the recombinant human serum albumin is highly secure and meets the requirements of safety, efficiency and quality in the clinical research.

The entry of this injection into the clinical research is a milestone in the research and utilization of plant bioreactors in China, which hews out a new path of bio-pharmaceuticals. This achievement makes China's plant bioreactor and third generation of transgenic technology research and industrialization remain in the international forefront. For the next stage, the project team will conduct clinical trials to test the safety and efficacy of the recombinant human serum albumin injection. Once given the production approval after the clinical validation, the drug will enter the hospital. This will greatly ease the tense supply of serum albumin in China, block the dissemination risk caused by AIDS and hepatitis virus, reduce dependence on imported serum albumin, and generate huge economic and social benefits.

Yang Daichang, the father of this achievement, went through a rocky road to school. However, he managed to overcome all the difficulties with his devotion and determination. In 2005, after several years’ oversea study, he was invited to teach in Wuhan University, his alma mater. Since then, he insisted on the original innovation with the target at the major domestic demands. For 12 years, he has been devoted to human serum albumin recombinant technology through plant bioreactor production regardless of others’ indifference and such difficulties as funds and venues deficiency. Eventually, his dedication turned the impossible into the possible.

In 2009, Hubei Province entrusted Wuhan University to take the lead in the construction of the province's first new industrial technology research institute - Wuhan Biotechnology Research Institute. It is established to specialize in bio-industrial application research, technical services and results transformation, and as a driver to boost industry upgrading and transformation. In 2010, Yang’s team won the first entry. The following year, the recombinant protein and peptide purification technology research platform presided by Yang ends in successful debugging. In 2014, a pilot production line with an annual output of one ton production capacity was established together with the construction of the complete industrialization system of plant bioreactor platform for rice endosperm bioreactor expression technology platform and protein purification technology platform. This has laid the foundation for recombinant human serum albumin research.

Since 2006, Yang has successively received support from the national high-tech "863" key plan, the national transgenic, new drug creation and other major scientific and technological projects, strategic emerging industry regional aggregation projects and provincial and municipal agencies. In 2011, he published the paper "The use of rice scale production of recombinant human serum albumin (rHSA)" in the internationally renowned academic journal "American Academy of Sciences" (PNAS), which has triggered wide attention in the international community. He has been selected for the seventh batch of Thousand Talents Program“, and he is also the recipient of the second award of national invention of science and technology, the outstanding patent award of the National Intellectual Property Patent Office, the first award of Hubei province technology invention. Besides, he has won eight national patents and 14 international authorized patents. In 2015, the incubation business-Wuhan Heyuan Biological Technology Co., Ltd. has been listed in the “new three board” and this company is based on Yang’s scientific and technological achievements.

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Professor Yang Daichang

 (Rewritten by Wang Meifang, Edited by Shen Yuxi, Hu Sijia )

 

 

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