Stability of Immune Globulin Intravenous, Human-stwk, 10% Liquid Following Pooling and Storage in Flexible Containers

Introduction Immune globulin intravenous, human-stwk, 10% liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. Unopened immune globulin intravenous, human-stwk, 10% liquid in its original container may be stored under refrigerated conditions at (2-8°C/36-46°F) for 36 months or may be stored for 24 months at room temperature (25°C/77°F) from the date it was manufactured. However, pooling intravenous immune globulin from several vials into a single container (usually a flexible bag) under aseptic conditions prior to administration is sometimes desirable in clinical practice. Purpose The purpose of this study was to determine the effects of pooling immune globulin intravenous, human-stwk, 10% liquid in 3 types of flexible containers under aseptic conditions. Methods Pooling of the immune globulin intravenous, human-stwk, 10% liquid was performed aseptically in a biological safety cabinet. The product was pooled into 3 types of empty containers: a polyolefin container, an EVA 2-port container, and a 3-in-1 EVA container. The following attributes were evaluated to determine product stability and quality at days 0, 1, 7, and 14: pH, total protein composition, osmolality, molecular size distribution (IgG monomers plus dimers, IgG fragments, IgG polymers), anti-complement activity, hepatitis B antibody titer, appearance, particle matter, thrombin generation activity, endotoxin, and sterility. Conclusion Pooled immune globulin intravenous, human-stwk, 10% liquid remained within release specifications (which are the FDA-approved requirements for immune globulin intravenous, human-stwk, 10% liquid) for all parameters evaluated for up to 14 days when stored under refrigerated conditions (2-8°C/36-46°F) in 3 commercially available flexible containers.