Applicability of QbD for Vaccine Drug Product Development

Vaccines consist of a heterogeneous group of biopharmaceuticals and the development of vaccines has more challenges than those for therapeutic proteins or small molecules with the more stringent regulatory oversight, much larger clinical trials, higher cost, and more complexity associated. It requires the products to be safe, efficacious with robust and scalable processes utilizing different technologies based on the biology and type of vaccine. This chapter presents an overview of challenges in vaccine development with special attention on analytical assay, formulation and process development, and the route toward quality by design for vaccines. Although simply employing Quality by Design (QbD) during the vaccine product development cycle may not lead to regulatory relief during licensure, QbD can be very helpful in understanding vaccine processes and can potentially improve vaccine production by making the process less empirical and more consistent in terms of quality.