The new method has obvious advantages over traditional influenza vaccine production

2023-11-02

Traditional influenza vaccines are produced using chicken embryo tissue and require stacked eggs, making it difficult to achieve automation and large-scale production. On November 1st, Yang Xiaoming, Chief Engineer of China National Pharmaceutical Group and Chief Scientist of China Biology, told Science and Technology Daily that producing influenza vaccines from mammalian cells not only improves the immune activity of vaccines, but also makes vaccine production intelligent and large-scale. Recently, the first domestically produced cell-based influenza vaccine based on a cell line independently developed by China Biotech has been approved for phase III clinical trials. At the same time, the influenza vaccine production line, which integrates intelligent robot equipment, large-scale basket bioreactor clusters, sheet-like carrier cultivation systems, and ultra large scale purification systems, has been completed in China. It is difficult to imagine that eggs, which people often eat, are an important raw material for producing influenza vaccines. The World Health Organization publishes the current year's epidemic strains every year, and vaccine manufacturers choose the corresponding vaccine strains to cultivate and produce vaccines in eggs. The production of influenza vaccines from chicken embryos has played an important role in controlling influenza, but there are also limitations, "Yang Xiaoming explained. Some influenza viruses, such as the H3N2 pandemic strain in 2003, have low production in chicken embryos. In addition, egg production and quality can have an impact on the safe and stable production of vaccines. Compared to chicken embryos, each batch of cells used for production is scaled up in a sterile environment, which ensures greater safety. Yang Xiaoming said that in terms of effectiveness, as mammalian cells are closer to human cells than avian cells, the vaccines cultivated from them have higher immune activity in the human body. Replacing chicken embryo culture with cell culture has become a consensus in the industry for upgrading and iterating influenza vaccines. The US FDA has previously approved the marketing of influenza vaccines for cell culture. Based on their safety and efficacy, this type of vaccine was approved for use in populations aged 6 months and above in 2021. The development of mammalian cell lines is crucial for the production of cell-based influenza vaccines, "Yang Xiaoming said. In order to develop cell lines with independent intellectual property rights, the team continues to conduct basic research on the growth characteristics, tumorigenicity, and tumorigenic mechanisms of MDCK cell lines (a basic cell line); On this basis, multiple rounds of screening were carried out using single cell cloning technology. After repeated research on the final and ultra-high generation cells, it was proven that a self owned cell line suitable for influenza virus proliferation was constructed. When it comes to the details of technological innovation, Yang Xiaoming gave an example: "For example, the industry is concerned that there may be tumorigenic substances in cell products, and we have innovated our technology to separate and remove them. The separation standards are several times higher than foreign standards, and far above the safety limit." The output will exceed one billion doses. "Accelerating the application of digital, intelligent, and green new production technologies can accelerate the realization of new industrialization," Yang Xiaoming believes, The iterative upgrading of the vaccine production industry requires disruptive innovation in traditional processes. In the past, the production process of chicken embryo influenza vaccines required stacked eggs, which not only occupied a large amount of space and consumed a lot of energy such as water and electricity, but also relied mainly on manual repetitive operations, making it difficult to carry out digital and intelligent transformation. As the culture medium changes from the source, modern bioreactors can completely change the production of influenza vaccines

Edit:GuoGuo    Responsible editor:FangZhiYou

Source:people.cn

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