Abstracto

Comparability of biotherapeutics: characterization of protein vaccine antigens

Marina Kirkitadze*,Arun Arunachalam and Bruce Carpick

Advances in biotechnology and analytical tools now permit the application of extensive analytical characterization packages to purified recombinant proteins, a significant progression from the traditional characterization of complex biological products primarily by their manufacturing process. In this article, the authors focus on comparability assessment of biotherapeutics, specifically vaccine protein antigens. Regulatory drivers and analytical approaches used to examine product comparability are discussed and two case studies are described in detail to demonstrate the comparability of pre- and post-change product at the early and late stages of vaccine development. In coming years the number of comparability studies will likely increase due to the greater number of vaccine manufacturers, production at multiple sites and with external partners, and the introduction of innovative process technologies. Comparability studies may be focused on only a few changes, or may be more extensive, to address the impact of multiple process changes at various stages of manufacturing.