ABSTRACT
As for any other pharmaceutical or biopharmaceutical productions, viral vaccines productions are highly regulated processes. National or supra‐national regulatory agencies provide detailed guidelines for product release for clinical use is subject to demonstration of safety and potency of the products. Potency and safety are assessed through validated quantification and characterization methods of the products. In this chapter, we will review the established tools and technologies allowing to quantify and qualify viral products and monitor viral production process parameters. We will also discuss the principles and good practices to implement new analytical technologies in the development stages of viral production processes.
