Although techniques have greatly improved over the years to generate purer high-quality products and reproducible processes while maintaining or decreasing the cost of goods, regulatory agencies are increasingly stringent regarding product identity and characterization of the end products and level of acceptable impurities as a way to ensure public safety and maintain public trust in this class of medicine. Purification process unit operations usually start with harvest and clarification, followed by intermediate purification steps, before polishing and formulation steps. The manufacturing of viral vector and viral vaccine products has always been paved with challenges related to the downstream processing. These enveloped viruses are produced in various systems, including traditional embryonated chicken eggs or more advanced cell culture technologies such as MRC-5 cells, Vero cells and HEK293-derived cell lines.
Enveloped viruses are encased in a lipid bilayer which, in most cases, fuses with the target host cell membrane to infect cells. About 14% of vaccines approved by the FDA involve enveloped viruses, while out of the 15 gene therapy products approved worldwide in 2019, six of them use enveloped viruses, and 39% of gene therapy clinical trials are using enveloped viruses. Viral vectors and viral vaccines are invaluable tools in prevention and treatment of diseases.
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