Protein Subunit Vaccine Purification

Protein antigens are key components of prophylactic vaccines against infectious diseases. The purification of protein antigens to achieve consistent product purity and quality is an integral part of the protein subunit vaccine product development process. Analogous to the biotech and biopharmaceutical companies, the vaccine industry has benefited from the recent progresses made in protein purification technology development or improvement, including disposable technology, membrane technology, high throughput process development, process automation, and process data tracking and analysis. This chapter reviews the methods, technologies, and processes used in protein subunit purification to support vaccine production and manufacturing. Some of the key technical issues encountered during the protein subunit vaccine purification are discussed, as well as the current status and future application of process analytical technology. In addition, an outlook and trends to support future needs in protein subunit vaccine purification are explored.