ABSTRACT
Many proteins in aqueous solution are susceptible to interfacial denaturation and precipitation during mechanical agitation. With the large number of protein parenteral products currently in research or clinical testing, it is important not only to understand this denaturation process but also to develop effective methods for stabilizing the products. Surfactants, such as Polysorbate 80 or sodium dodecyl sulfate (SDS), are frequently used to stabilize parenteral products. While it is a commonly accepted technique, little has been published about the precipitation and stabilization processes in general. We describe the stabilization of antibody products in solution by preferential adsorption of a water-soluble, non-ionic surfactant at the air-liquid interface. Data are presented from antibody and immunotoxin solution shake studies and surface tension measurements to support the utility of surface tension measurements in formulation design.
