End of production cell bank

Cells grow from a single vial (1-5 mL) to thousands of liters in bioreactors. Many generations of cell division and growth are involved. It is important that in this process, which may last from weeks to months, the cells do not mutate and faithfully express the intended protein. Cells at the completion of production are collected as samples and grown further as an end of production cell bank (EPCB). Analysis conducted on the products from the EPCB is to verify that the protein is produced properly, even after many generations of cell reproductions. 

Establishment Inspection Report Establishment License Application enzyme linked immunosorbent assay European Medicines Agency Environmental Protection Agency European Public Assessment Report end of production cell bank erythropoietin... 

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