The cell culture industry emerged in the 1980s with the advent of recombinant DNA technology and cell engineering. This industry is also the main promoter of the pharmaceutical market, and a large share of this market is gradually occupied by biological agents. In the next few years, not only the contribution of the cell culture industry may show an explosive growth, but also the contribution of the mammalian cell culture industry will play a major role. In the emerging field of the biopharmaceutical market, ProBiogen in Berlin, Germany, has achieved initial success and its new bioreactor technology has received industry recognition.
ProBioGen was founded in 1994 as a manufacturer of in vitro diagnostic products. Six years later, the company realized that they should make full use of their expertise and expertise to become first-rate experts in the field of cell lines and provide cGMP production services under the contract. Therefore, CEO Michael Schlenk reformed the company's business model. At the same time, they also began to improve the services related to the process from the gene to the market, covering every step in the process from protein expression to cGMP manufacturing, including technical support for complete project operations.
ProBioGen's unique selling point lies in its cell line engineering capabilities. They have accumulated rich experience and expertise in the cultivation of primary cells from animals to humans, providing a large number of pre-customizable cell lines, trying to meet all the needs of the unified customization and the special needs of consumers. The company's development is based on the patent rights to the Cell Line Engineering Platform, which produces optimal and license-free CHO cell lines for consumers, and takes 6 months from the acquisition of genes to the acquisition of mature cell lines. Can be completed.
In addition to providing customized cell lines for consumers, companies can also provide patents on primary cells to allow users to obtain licenses. Currently, the company has patents on two cell lines: one is the avian cell line developed from duck embryos. This cell line is suitable for producing a wide range of human and animal vaccines, and the other is derived from human neural cell precursor tissues. Human neuronal cell line.
Viral vaccine for the production of avian cell lines
"Currently, the main medium for the production of human vaccines is chicken eggs and chicken embryo fibroblasts. Although these media allow many viruses including attenuated strains to proliferate in it, there are still many obvious costs in vaccines. The disadvantages," said Volker Sandig, vice president of the viral and molecular biology division of ProBioGen, said, "As the animal's primary cells, these cells are also aging, so each batch of cells need to be freshly prepared. This requires the production of the cells. Populations should not contain pathogens and should be tested frequently. These cells also need to be cultured on the surface of solid medium containing fetal bovine serum, so the production process is very complicated."
These difficulties not only increase costs, but if they are encountered, they will also pose considerable obstacles to the production of vaccines because the production capacity cannot rapidly increase. To overcome these difficulties and maximize safety, ProBioGen developed a patented permanent cell line derived from duck embryos. The entire R&D process was conducted in a dedicated GMP environment. The company also provided documentation data for the entire R&D process so that the cell line could be used for the development of clinical materials. In addition, unlike the transfected chicken cells and their primary cells, our cell line showed a lack of retroviral activity after Q-PERT analysis. The Q-PERT assay was used to quantitatively detect the reverse transcriptase activity of vaccines and cell lines.
ProBioGen's avian cell line is derived from different tissues induced by non-viral genes that induce cell proliferation and inhibit apoptosis. Two of these cell lines are now stably maintained for more than a year and a half, one of which has been able to grow in an excitation system without animal cell culture medium, so that the cell line can be used for the large-scale production of viruses. This cell line can be subcultured at a rate of 10 to 15 passages per week at a concentration of 9106 cells/ml. The cell line also allows MVA and fowlpox to proliferate, and both viral vaccines are important platforms for constructing recombinant virus vaccines. Virus titers can reach or even exceed the levels of virus titers obtained with primary chicken cell lines. They can also be used for the proliferation of influenza strains and flaviviruses, parvoviridae, and rhabdoviruses. The current data obtained from influenza strains are indeed encouraging.
"The combination of service and innovative technology constitutes a balance between corporate risk and profit. Providers providing services provide us with stable funding, allowing us to focus on selected, highly innovative and market-proven products. R&D,†Mr. Schlenk commented. “This combination allowed us to position ourselves as the most innovative and reliable partner in the biologics industry. In addition, we are expanding activities outside the United States and Europe and are seeking Prospective biotechnology centers around the world, including China.â€
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