Case study of viral safety tests applied to recombinant bioproducts and vaccines

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This activity presents the fundamentals of the regulatory framework and viral safety for recombinant bioproducts. It also covers the manufacturing process and the principles of the testing strategy to ensure product safety and quality.

This activity explores the specific regulatory requirements for vaccines and the manufacturing process of an inactivated viral vaccine, covering the different categories of virological tests needed to ensure their efficacy and purity.

This activity focuses on sample management and the manufacturer's responsibilities to ensure test quality, covering general sample management principles, the sample lifecycle, and inactivation control tests for inactivated viral vaccines