Process Development for Cell-Based Influenza Vaccine

摘要

Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes. The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different focus areas in live influenza processing are described: Optimization of a disposable cell culture step; a downstream purification process for efficient removal of genomic DNA (gDNA) from live influenza virus cultured in Madine-Darby Canine Kidney (MDCK) cells; and development of a fast, accurate live influenza assay.