Process steps for the fractionation of immunoglobulin (Ig) G depleted of IgA, isoagglutinins, and devoid of in vitro thrombogenicity.

Background: Plasma-derived immunoglobulins (IgG) are essential medicines that are in worldwide shortage, especially in low- and middle-income countries. Optimised manufacturing processes can increase supply. We evaluated various new process steps for IgG fractionation.