Input 2021.02.08 17:34 | Revision 2021.02.08 17:41
Cell culture → neutralizing antibody purification → product completion automation process–
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Kang-rip Kim, head of the Ministry of Food and Drug Safety, visited the production site of Rekkirona, which will make up to 3 million people annually at 2 pm on the 8th. Celltrion Plant 2 in Songdo, Yeonsu-gu, Incheon, is a four-story building that was completed in 2010. The first to third floors are production spaces and the fourth floors are office spaces. Although actual production has not yet been carried out, it will be operated together with the first plant when demand increases.
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Cell culture takes a total of 40 days. Transfer the frozen cells to -180 °C into an incubator and start culturing. When the cells grow to a certain size in the incubator, they are transferred to a larger incubator that can grow to a larger size. The largest incubator is 15,000 liters (liter), and there are six in the second plant. A total of 190,000 liters of cell culture is possible every 3 days in the 1st and 2nd factories, and although it varies depending on the production yield, it can produce up to 3 million people’s worth of Leckirona per year.
Completely cultured cells are transferred to a purification room and a finished room equipped with sterilization and washing facilities. The purification room is a place where neutralizing antibodies, the main component of therapeutic agents, are obtained from cells. It takes about 4-5 days. After purification, the drug substance is finally obtained.
In the finished product room, a finished drug with a dose of 960 mg that can be actually administered to humans is made. The company introduced that sterilization and washing are carried out thoroughly like in the refinery.
Currently, the 100,000 servings produced by Celltrion at its 1st factory are mixed with raw materials that went through the refinery and finished drugs. The company did not disclose exactly the quantity of the finished drug, but said, “We are packing some parts for shipment.”
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