• chromatography
• human plasma
• immunoglobulins

The aim of this research project is to develop a new chromatography-based manufacturing process of an immunoglobulin G (IgG) concentrate for intravenous administration, starting from human plasma. The presented experimental data shows that it is possible to purify IgG from an upstream plasma fraction (obtained by Cohn’s fractionation) by two chromatographic steps (a capture step and a polishing step), and to formulate it properly for its intended use. The general approach to protein purification, the international guidelines about manufacturing and viral safety of biopharmaceutical products, and the most recent marketing suggestions were taken as a reference during the development work.