The manufacturing of biologics is complex, since most are proteins—large molecules often variable in structure and sensitive to environmental conditions. The manufacturing of biologics has become a science that can be summarized in four key steps: producing the master cell line, growing cells and producing protein, isolating and purifying protein from cells, and preparing the biologic for patients. The whole process from creating the master cell bank to preparing the biologic for patients can take years and cost hundreds of millions of dollars.

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